Easing the Sting: A Paired Crossover Study Comparing Pain Relief with EMLA Cream vs Digital Distraction During Pediatric IV Cannulation | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Easing the Sting: A Paired Crossover Study Comparing Pain Relief with EMLA Cream vs Digital Distraction During Pediatric IV Cannulation Neha Thakur Rai, Shruti Jain, Aaditya Katyal This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8193507/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 11 You are reading this latest preprint version Abstract Background Intravenous (IV) cannulation is among the most common and distressing procedures in pediatric care. Eutectic Mixture of Local Anesthetics (EMLA) cream is a widely used pharmacological analgesic, while Digital Distraction (DD) is a feasible non-pharmacological strategy in low- and middle-income settings. However, high-quality comparative evidence—particularly using a paired, crossover design—is limited. This study compared the effectiveness of EMLA cream versus standardized digital distraction in reducing procedural pain during pediatric IV cannulation. Methods This quasi-experimental non-randomized paired crossover study, reported in accordance with the TREND guidelines, was conducted in the Pediatric Care Unit of a tertiary-care teaching hospital in Northern India. Children aged 5–12 years requiring two IV cannulations were enrolled. Allocation of the first intervention was made based on parental preference, and each child subsequently crossed over to receive the alternate method at the next clinically indicated cannulation. EMLA was applied 45–60 minutes before cannulation. DD consisted of standardized offline age-appropriate cartoon videos shown 10–15 minutes before, during, and after cannulation. Pain was assessed at 0, 1, and 3 minutes post-insertion using the Wong–Baker FACES Pain Rating Scale (WBFPS). Pain assessments were performed by a blinded independent observer scoring video-recorded facial expressions. Paired comparisons were analyzed using the Wilcoxon signed-rank test, with a 1-point non-inferiority margin which was defined a priori. Results A total of 161 children completed both intervention phases. Pain scores were consistently lower with EMLA at all three time points. Median paired differences favored EMLA at 0 minutes (EMLA: 8 [IQR 6–10] vs. DD: 8 [ 6 – 10 ]), 1 minute (EMLA: 8 [ 4 – 10 ] vs. DD: 8 [ 6 – 10 ]), and 3 minutes (EMLA: 6 [ 4 – 8 ] vs. DD: 6 [ 4 – 8 ]), with significantly smaller increases from baseline in the EMLA phase (p < 0.001 across all time points). The upper bounds of the 95% confidence intervals exceeded the 1-point non-inferiority margin; DD was not non-inferior. No adverse events occurred. Conclusion In this crossover study, EMLA cream provided superior procedural analgesia compared with digital distraction at all post-cannulation time points. While DD offered partial pain reduction, it did not achieve non-inferiority and may be best used as an adjunct in settings where topical anesthetics are unavailable or impractical. Combined application of pharmacological and digital distraction strategies may offer optimal pediatric comfort during IV procedures. pediatric pain intravenous cannulation EMLA digital distraction crossover study procedural analgesia TREND Figures Figure 1 Figure 2 INTRODUCTION Effective management of procedural pain is a critical yet often overlooked component of pediatric healthcare. Needle-related procedures such as venipuncture and intravenous (IV) cannulation are among the most frequent sources of acute pain for children, and inadequately treated pain can have lasting physiological and psychological consequences. Stevens highlights that pain in children is a multidimensional experience involving emotional, cognitive, and behavioral domains, highlighting the need for comprehensive management strategies [ 1 ]. Despite this, pediatric pain is frequently underestimated and undertreated, as emphasized by the American Academy of Pediatrics (AAP), which calls for structured pain assessment and timely analgesic interventions for infants and children undergoing invasive procedures [ 2 ]. Topical anesthetics such as the Eutectic Mixture of Local Anesthetics (EMLA) cream have been widely used to reduce procedural pain. Evidence from several clinical studies and reviews indicates that EMLA effectively decreases discomfort associated with venipuncture and IV catheter placement in pediatric patients [ 3 – 5 ]. Its analgesic effect and safety profile make it a standard option in many pediatric units. However, EMLA requires 45–60 minutes to achieve sufficient dermal anesthesia, and its availability and cost can limit use in high-volume or resource-constrained settings typical of low- and middle-income countries (LMICs). These limitations highlight the need for practical, rapidly deployable alternatives. Digital Distraction (DD) represents a non-pharmacological alternative grounded in attentional control theory, which posits that directing cognitive resources toward immersive visual and auditory stimuli reduces the perceptual salience of painful input. Age-appropriate animated videos act by capturing and sustaining the child’s attentional bandwidth, thereby modulating pain interpretation at the cortical level. Prior studies demonstrate that distraction reduces both perceived pain and distress in children undergoing medical procedures such as laceration repair and immunization [ 6 – 12 ]. Digital technology–based distraction has shown encouraging results; a recent meta-analysis reported that digital tools significantly reduce acute procedural pain in children, supporting their role in modern pediatric pain protocols [ 13 ]. Nonetheless, key gaps remain. First, although both EMLA and Digital Distraction (DD) have shown individual efficacy, direct head-to-head comparisons within the same pediatric population are scarce, especially in LMIC settings where decisions must consider feasibility, cost, and time constraints. Second, prior studies often differ in methodology, content used for distraction, and pain assessment strategies, making cross-study comparisons challenging. Third, as highlighted by previous authors, the subjective nature of pain scoring introduces potential inter- and intra-observer variability, necessitating careful design to minimize bias [ 14 – 16 ]. Despite evidence supporting both modalities independently, direct comparative data between EMLA and standardized Digital Distraction during pediatric IV cannulation are limited, particularly in the Indian context. Many distraction studies also use heterogeneous content, making comparisons difficult. Given known inter-individual variability in pain perception and coping styles among children, a crossover design—in which each child receives both interventions—allows for more precise within-subject comparison by minimizing baseline variability. Given these considerations, the present study was conducted to address the lack of direct comparative evidence between EMLA cream and DD in pediatric IV cannulation. The primary objective was to compare procedural pain at 0, 1 and 3 minutes post-cannulation using the Wong–Baker FACES Pain Rating Scale (WBFPS) among children aged 5–12 years who experienced both interventions in a quasi-experimental crossover design. In accordance with attentional and pharmacologic mechanistic principles, we established a 1-point non-inferiority margin to evaluate whether Digital Distraction could match the analgesic performance of EMLA. By comparing a pharmacologic analgesic with a feasible digital distraction strategy within the same cohort of children, this study aims to provide practical, contextually relevant evidence for improving pediatric procedural pain management in resource-limited clinical environments. METHODS This quasi-experimental, non-randomized crossover trial was conducted over a period of one year in the Department of Pediatrics at a tertiary care teaching hospital in Northern India and reported in accordance with the TREND guidelines [17]. The study evaluated whether Digital Distraction (DD) was non-inferior to EMLA cream in reducing procedural pain during intravenous (IV) cannulation in children aged 5–12 years. Ethical clearance was obtained from the Institutional Ethics Committee (IEC No. RC-791-22-06-2023). Participants and Eligibility Children aged 5–12 years who required two clinically indicated IV cannulations during their admission were screened. Eligibility criteria included: being conscious, clinically stable, able to self-report pain, and not receiving sedatives, anticonvulsants, or systemic analgesics at the time of the procedure. Exclusion criteria included audio-visual impairment, dermatologic abnormalities at the cannulation site, known hypersensitivity to lidocaine–prilocaine, or significant hepatic, renal, or cardiac disease. Participants were recruited using consecutive sampling from the Pediatric Care Unit, Emergency, and general pediatric wards. Written informed consent was obtained from parents or legal guardians, and assent was obtained from children aged ≥7 years. Sample Size Calculation The sample size was determined a priori using a non-inferiority framework. Calculations were based on data from Yıldırım et al. (2013), who compared virtual reality (VR) distraction with standard care in children undergoing painful procedures [16]. In that study, the VR distraction group had a mean WBFPS score of 5.6 ± 1.9, while the control group had a mean of 6.2 ± 1.0. Using a two-sided alpha of 0.05, 90% power, an allocation ratio of 1:1, and a clinically meaningful non-inferiority margin of 10% (equivalent to 0.6 points on the WBFPS scale), the minimum required sample size was 68 children per group (136 total). Accounting for 10% attrition, the final sample size target was 150, and 161 children completed both phases. Interventions Assignment to receive EMLA first or digital distraction (DD) first was based on parental preference after a detailed explanation of both interventions. The study used a paired crossover design in which every child received both interventions during two separate cannulation attempts, allowing each participant to serve as their own control. Some children received EMLA before the first cannulation and DD during the second, while others received the reverse sequence. The second cannulation occurred later during the hospital stay, which helped control for individual variations in baseline pain tolerance and familiarity with the procedure. EMLA cream, a eutectic mixture containing 2.5% lidocaine and 2.5% prilocaine, was applied at a dose of roughly 1 g per 10 cm², with a maximum of 2 g per site in accordance with pediatric FDA recommendations. Older children (7–12 years, weighing more than 20 kg) could receive up to 20 g over 200 cm² for up to four hours. The cream was applied 45–60 minutes before cannulation under an occlusive dressing, and the skin was examined on removal for erythema, edema, or other local reactions. Digital distraction consisted of a standardized set of preloaded, offline animated cartoon videos selected for age appropriateness and visual engagement. These videos were shown beginning 10–15 minutes before cannulation, continued throughout the procedure, and extended for three minutes afterward. The device was positioned in the child’s direct line of sight, and adherence to the distraction protocol was ensured by a trained staff member or simulation technician. Each child formed the unit of delivery and analysis, and interventions were administered individually with no cluster effects. Fidelity was maintained through preloaded uniform content, fixed viewing angles, and the absence of co-interventions. The study aimed to compare procedural pain between EMLA and DD, evaluating whether DD was non-inferior to EMLA within a one-point margin on the Wong–Baker FACES Pain Rating Scale (WBFPS). Pain was assessed at 0, 1, and 3 minutes after cannulation by a trained independent assessor who was blinded to intervention identity through the use of coded, audio-free video recordings. Because the nature of the interventions made participant and clinician blinding impossible, outcome blinding was strictly preserved. Pain scores were non-normally distributed based on Shapiro–Wilk testing. Paired differences between interventions at each time point were analyzed with the Wilcoxon signed-rank test. Prespecified subgroup analyses examined effects of prior painful experiences, cannulation site and cannula gauge. No imputation was required because all participants completed both phases. Analyses were performed using IBM SPSS version 21, with statistical significance set at p ≤ 0.05, and a predefined non-inferiority margin of 10% to represent a clinically meaningful difference in pain scores. RESULTS A total of 204 children were screened for eligibility, of whom 43 were excluded (27 did not meet inclusion criteria, 12 declined participation, and 4 were unable to complete the protocol for logistical reasons). The remaining 161 children were enrolled, provided assent/consent, and completed both intervention phases without loss to follow-up or protocol deviations. Of these, 68 children received EMLA first , and 93 received Digital Distraction first , in accordance with parental preference for the initial procedure. All participants subsequently crossed over to the alternate intervention at the second clinically indicated cannulation, resulting in paired data for all children (Fig 1). Recruitment occurred between July 2023 and June 2024 . Baseline demographic and clinical characteristics are summarised in Table 1. The two initial sequence groups—those receiving EMLA first (Sequence A) and those receiving Digital Distraction first (Sequence B)—were comparable across all key variables, including age, sex distribution, prior venepuncture exposure, underlying comorbidities, cannulation site, and cannula gauge. As all enrolled children completed both intervention phases, no further comparisons between retained and lost participants were necessary. No adverse effects or unintended events (e.g., erythema, edema, hypersensitivity) were observed in either intervention phase. Table 1: Baseline characteristics of the study population (n = 161). Variables n=161(%) Age Group 5-8 years 97 (60.2) 64 (39.8) 100 (62.1) 61 (37.9) 9-12 years Sex Male Female Previous venepuncture experience 10 times 30 (18.6) Previous episode of any painful medical procedure besides IV cannulation No 134 (83.2) Yes 27 (16.8) Previous hospitalization No 97 (60.2) Yes 64 (39.8) Previous surgery No 144 (89.4) Yes 17 (10.6) Pre-existing skin conditions No 118 (73.3) Yes 43 (26.7) Developmental milestones Appropriate for age 156 (96.9) Delayed for age 5 (3.1) Congenital abnormalities No 157 (97.5) Yes 4 (2.5) Site of I.V. cannulation Dorsum of hand 115 (71.4) Forearm 36 (22.4) Others 10 (6.2) Size of cannula 24 Gauge 109 (67.7) 22 Gauge 48 (29.8) 20 Gauge 4 (2.5) Immunization Up to date 139 (86.3) Partially immunized till date 21 (13) Unimmunized till date 1 (0.6) Admission at birth No 136 (84.5) Yes 25 (15.5) Previous history of illness No 82 (50.9) Yes 79 (49.1) Documented allergies No 136 (84.5) Yes 25 (15.5) First cannulation done with Digital Distraction 93 (57.8) EMLA cream 68 (42.24) Duration of hospital stay 2-6 days 74 (46) 7-11 days 55 (34.2) 12-16 days 17 (10.6) More than 16 days 15 (9.3) Previous blood sampling experience 2 to 5 times in a week 102 (63.4) 6 to 9 times in a week 52 (32.3) 10 to 12 times in a week 7 (4.3) Paired comparisons demonstrated that EMLA consistently resulted in significantly lower pain scores than Digital Distraction at all measured timepoints. At 0 minutes, immediately after cannulation, both interventions showed an expected rise from baseline; however, the rise was significantly smaller under EMLA (Wilcoxon Z = –10.567, p < 0.001) compared with DD (Z = –11.36, p < 0.001). The median paired difference exceeded the predefined 1-point non-inferiority margin, indicating that DD was not non-inferior to EMLA at peak procedural pain. At 1 minute, pain had begun to decline in both conditions, but remained significantly lower with EMLA (Z = –7.576, p < 0.001) than with DD (Z = –10.315, p < 0.001). By 3 minutes, pain continued to fall, with EMLA again demonstrating a more favorable trajectory (Z = –1.126, p < 0.001) compared with DD (Z = –6.588, p < 0.001). Across all intervals, the observed paired differences exceeded the non-inferiority limit, confirming that Digital Distraction was not non-inferior to EMLA for procedural analgesia. Within each intervention, pain decreased significantly over time. The reduction from 0→1 minute and 0→3 minutes was significant in both groups, but the magnitude of decline was greater and more consistent with EMLA, indicating a more stable analgesic effect (Table 2, Figure 2). Table 2: Paired comparison of pain scores (WBFPS) between Digital Distraction and EMLA at each time point. Time Interval Wong Baker FACES Pain Scale DD EMLA Pre insertion to 0 minutes Mean pre 4(4,8) 6(4,8) Mean 0 8(6,10) 8(6,10) Wilcoxon -11.36 -10.567 p-value <0.001* <0.001* Pre insertion to 1 minutes Mean pre 4(4,8) 6(4,8) Mean 1 8(6,10) 8(4,10) Wilcoxon -10.315 -7.576 p-value <0.001* <0.001* Pre insertion to 3 minutes Mean pre 4(4,8) 6(4,8) Mean 3 6(4,8) 6(4,8) Wilcoxon -6.588 -1.126 p-value <0.001* <0.001* 0 to 1 minutes Mean 0 8(6,10) 8(6,10) Mean 1 8(6,10) 8(4,10) Wilcoxon -6.48 -8.088 p-value <0.001* <0.001* 0 to 3 minutes Mean 0 8(6,10) 8(6,10) Mean 3 6(4,8) 6(4,8) Wilcoxon -10.603 -11.953 p-value <0.001* <0.001* 1 to 3 minutes Mean 1 8(6,10) 8(4,10) Mean 3 6(4,8) 6(4,8) Wilcoxon -9.296 -9.015 p-value <0.001* <0.001* Subgroup Analyses A. Previous painful experiences Children with and without prior painful procedures showed similar patterns: EMLA consistently produced lower pain scores across all time points. Prior procedural exposure did not significantly modify the comparative effectiveness (Table 3A). B. Cannulation site Pain intensity varied by site, with procedures on the dorsum of the hand generally producing higher discomfort. Even in these more painful sites, EMLA outperformed DD across all time points, with statistically significant differences particularly evident at 1 minute post-insertion (Table 3B). C. Cannula gauge Pain tended to be higher with larger-gauge cannulas (20G > 22G > 24G). Across all gauge sizes, EMLA continued to yield more favorable pain profiles. Significant differences were observed particularly for 20-gauge cannulations, where EMLA demonstrated considerably superior analgesia (Table 3C). TABLE 3: Subgroup analysis of procedural pain scores (DD vs. EMLA) Time stamp Pre-insertion 0 minutes 1 minute 3 minutes Group Other previous painful medical procedures M p-value M p-value M p-value M p-value A. WBFPS scores over time for Digital Distraction vs. EMLA cream in children with vs. without previous painful medical procedures DD No 2(1,3) 0.594 3(2,4) 0.432 3(2,4) 0.293 2(1,3) 0.888 Yes 2(2,3) 3(2,4) 2(2,4) 2(1,3) EC No 3(2,3) 0.573 4(2,4) 0.455 4(2,4) 0.424 3(2,3) 0.318 Yes 3(2,3) 3(2,4) 2(2,4) 2(2,3) B. WBFPS scores over time for Digital Distraction vs. EMLA cream by IV cannulation site (dorsum of hand, forearm, or other) DD Dorsum 4(4,8) 0.009* 8(6,10) 0.064 8(4,10) 0.038* 6(4,8) 0.110 Forearm 6(4,8) 8(8,10) 8(6.5,10) 6(6,8) Others 3(2,8) 7(4,10) 6(2,10) 5(2,10) EC Dorsum 6(4,8) 0.054 8(6,10) 0.356 8(4,10) 0.243 6(4,8) 0.200 Forearm 8(6,8) 8(8,10) 8(6,10) 6(6,8) Others 4(2,8) 6(4,10) 7(2,10) 5(2,8) C. WBFPS scores over time for Digital Distraction vs. EMLA cream by IV cannula size (20 vs. 22 vs. 24 gauge). Time stamp Pre-insertion 0 minutes 1 minute 3 minutes Group M p-value M p-value M p-value M p-value DD 20 7(4.5,8) 0.080 10(8.5,10) 0.006 10(8.5,10) 0.004 7(6,9.5) 0.057 22 4(2,6) 8(6,10) 6(4,10) 6(2,8) 24 4(4,8) 8(6,10) 8(6,10) 6(4,8) EC 20 6(4.5,7.5) 0.059 9(8,10) 0.018 9(8,10) 0.005 7(4.5,8) 0.084 22 6(2.5,7.5) 7(6,8) 6(4,8) 6(4,6) 24 6(4,8) 8(6,10) 8(4,10) 6(4,8) DISCUSSION This quasi-experimental crossover study compared the effectiveness of Digital Distraction (DD) and EMLA cream in reducing procedural pain during intravenous cannulation among children aged 5–12 years. The findings demonstrate that EMLA provided consistently superior pain relief across all measured intervals, while DD offered partial but insufficient analgesia to meet the predefined non-inferiority criterion. These findings are consistent with the proposed mechanisms of the interventions: EMLA exerts a pharmacologic dermal anesthetic effect, reducing nociceptive afferent signals at the site of needle insertion, whereas Digital Distraction relies on attentional shift—redirecting cognitive resources away from the painful stimulus through visual and auditory engagement. Although DD successfully lowered pain relative to baseline, it did not adequately attenuate the peak nociceptive response, which is better addressed by a pharmacological agent. The superiority of EMLA observed in this study is well supported by existing literature. Cordoni and Cordoni reported significant reductions in cannulation pain with EMLA [ 4 ], while Shrinivas and Kumar similarly demonstrated that topical anesthesia provides superior dermal analgesia compared with placebo [ 5 ]. Young et al. observed that EMLA applied before phlebotomy significantly improved pain tolerance [ 15 ], and Robieux et al. highlighted its clear benefit in reducing pain perception in pediatric venipuncture [ 18 ]. These previous findings confirm that EMLA reliably minimizes nociceptive input during needle procedures and directly align with the pain trajectories observed in our population. Digital distraction, although not non-inferior to EMLA, did reduce the rise in pain from baseline and showed a consistent downward trend in pain scores over time. This aligns with prior evidence demonstrating partial analgesic benefit with distraction. Sinha et al. found that distraction reduced distress during laceration repair [ 7 ], and Shahid et al. showed that distraction through iPads lowered pain during immunization [ 9 ]. Rao et al. similarly reported reductions in pain with virtual reality distraction [ 10 ]. These findings collectively support the role of DD as a helpful adjunctive modality based on attentional diversion. Furthermore, earlier work investigating distraction techniques has shown that while they can reduce distress and perceived discomfort, their effectiveness varies depending on the child’s engagement, the intensity of the painful stimulus, and the distraction content. Our standardized DD protocol minimized variability in content—a limitation often noted in distraction studies—yet the analgesic effect remained modest compared with EMLA. The attentional control theory underlying distraction posits that competing sensory input reduces cognitive capacity available for pain processing; however, during high-intensity, rapid-onset stimuli such as needle insertion, the efficacy of distraction appears limited. The work of Gates et al., which found significant variability in distraction-related analgesia across studies, further contextualizes why DD did not achieve non-inferiority [ 13 ]. The temporal profile of pain in this study also reinforces known physiological mechanisms. Pain peaked immediately after insertion for both interventions, reflecting the sharp nociceptive impact of skin penetration. However, pain declined more rapidly and consistently in the EMLA phase, demonstrating the sustained dermal blockade provided by the anesthetic mixture. This pattern is consistent with previous findings indicating that distraction is less effective when pain is intense or perceived as threatening, as highlighted by Van Damme et al. [ 6 ]. An important strength of this study is its crossover design, which allowed each child to serve as their own control. This reduces potential confounding arising from inter-individual differences in pain threshold, prior medical experiences, temperament, and coping strategies—factors that are especially relevant in pediatric behavioral research. The use of a blinded independent assessor reviewing video-recorded facial expressions further minimized observer bias. Additionally, the standardized distraction content and consistent procedural workflow improved fidelity and ensured that differences in performance were attributable to the interventions rather than contextual inconsistencies. Subgroup analyses reinforced the overall findings. EMLA maintained superior analgesia across cannulation sites, cannula gauges, and among children with or without previous painful medical experiences. Even in inherently more painful scenarios — such as dorsal hand cannulations or use of larger-gauge cannulas — EMLA demonstrated better pain control, proving its reliability across procedural contexts. These observations are consistent with earlier literature demonstrating the reproducibility of EMLA’s analgesic effects across varied clinical situations [ 3 , 19 – 21 ]. Despite these strengths, several potential sources of bias must be considered. First, the study employed non-randomized allocation based on parental preference, introducing the possibility of selection bias. Although the paired crossover design mitigated this risk, the initial assignment could still reflect parental expectations or child temperament. Second, participants and intervention deliverers were not blinded due to practical constraints inherent to behavioral and topical interventions. Third, as with all self-report pain scales, subjective interpretation remains a limitation despite using a validated tool and blinded scoring. Fourth, the absence of a formal washout period between interventions could theoretically result in carryover effects, although the natural clinical spacing between cannulations likely minimized this risk. Finally, the distraction effect may vary depending on the individual child’s preferences, interest level, or familiarity with digital media; while standardized content reduces variability, it cannot eliminate individual differences in engagement. Implementation fidelity was high, but practical barriers observed during workflow—such as maintaining device placement within the child’s line of sight or ensuring continuous engagement—highlight the challenges of integrating distraction consistently in dynamic clinical settings. In contrast, EMLA use requires preparation time and may not always be feasible in fast-paced emergency units. As noted by Gates et al., distraction techniques can be valuable in such environments when implemented consistently [ 13 ]. These contextual factors are important for interpreting real-world applicability. The findings carry pragmatic implications for pediatric procedural pain management, particularly in resource-limited settings. While EMLA remains the superior analgesic, its cost, availability, and required application time may limit routine use in high-volume pediatric units. Digital Distraction, despite not meeting non-inferiority criteria, demonstrated meaningful pain reduction relative to baseline and remains an accessible, low-cost adjunct that can enhance the overall procedural experience, especially where topical anesthetics cannot be used. Given that distraction has broader benefits in reducing anxiety and improving cooperation, it may still serve as an important supportive measure alongside pharmacological analgesia. Generalizability of these findings is strengthened by the pragmatic design, real-world clinical setting, and inclusion of a broad pediatric age range typical of cannulation scenarios. However, external validity may be influenced by local factors such as staff expertise, patient demographics, caregiver expectations, and availability of digital tools. Further studies could explore combined approaches—EMLA plus DD—and evaluate the additive benefits for child comfort and cooperation. In conclusion, this study demonstrates that EMLA cream provides superior analgesia at all measured intervals during pediatric intravenous cannulation, while Digital Distraction offers modest but meaningful reductions in pain. DD did not achieve non-inferiority and should therefore be considered an adjunct rather than a substitute for topical anesthesia. In settings where EMLA application is not possible, Digital Distraction remains a valuable, accessible alternative capable of enhancing the child’s overall experience. The methodological rigor, crossover design, standardized distraction protocol, and blinded assessment contribute to the reliability of the findings. Together, these findings support a multimodal approach to optimizing pediatric procedural comfort, particularly in resource-limited environments where balancing feasibility and analgesic efficacy is essential. Declarations Ethics approval and consent to participate All study procedures were performed in accordance with the ethical standards of the institutional research committee, the Indian Council of Medical Research (ICMR) guidelines, and the Declaration of Helsinki. Ethical approval for the study was obtained from the Institutional Ethics Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow (IEC No. RC-791-22-06-2023 ). Written informed consent was obtained from parents or legal guardians of all participating children, and assent was obtained from children aged 7 years and above. Consent for publication No identifiable images, videos, or personal details of participants are included in this manuscript. All data were fully anonymized before analysis. As per institutional guidelines, separate consent for publication was not required. Documentation from the ethics committee can be provided upon request. Availability of data and materials All data generated and analyzed during this study are included in this published article and its associated tables and figures. Additional supporting material or anonymized datasets are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests . Funding This research received no external funding . No financial support or grants were obtained for conducting the study or preparing the manuscript. Authors’ contributions NTR , and SJ conceptualized the study and developed the study design. SJ led protocol development, prepared the data collection forms, coordinated recruitment, while NTR supervised day-to-day conduct of the study. NTR performed the preliminary data cleaning and organisation, assisted by SJ , who also managed the video-based scoring workflow and ensured blinding procedures were maintained. AK contributed in refining the study methodology, developing the statistical analysis plan, and conducting the final analyses. He supported interpretation of findings, drafted major portions of the manuscript, integrated reviewer-directed revisions, and prepared the final submission-ready version. All authors participated in manuscript writing, critically reviewed all drafts for intellectual content, approved the final version, and agree to be accountable for all aspects of the work. Acknowledgements The authors gratefully acknowledge the support of the Department of Pediatrics, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow , and the nursing staff whose cooperation made this study possible. The authors also appreciate the guidance provided by the clinical and administrative teams throughout the study period. Authors’ information Department of Pediatrics , Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India Department of Emergency Medicine , Kasturba Medical College, Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India References Stevens B. Revisions to the IASP definition of pain-What does this mean for children? Paediatr Neonatal Pain. 2021 Mar 27;3(3):101-105. doi: 10.1002/pne2.12047. PMID: 35547949; PMCID: PMC8975187. American Academy of Pediatrics. Committee on Psychosocial Aspects of Child and Family Health; Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001 Sep;108(3):793-7. doi: 10.1542/peds.108.3.793. PMID: 11533354. Curtis S, Wingert A, Ali S. The Cochrane Library and Procedural Pain in Children: An Overview of Reviews. Evidence-based Child Health: A Cochrane Review Journal [Internet]. 2008 Jun 1;7(5):1363–99. Available from: http://onlinelibrary.wiley.com/doi/10.1002/ebch.1864/full Cordoni A, Cordoni LE. Eutectic mixture of local anaesthetics reduces pain during intravenous catheter insertion in the pediatric patient. Clin J Pain. 2001 Jun;17(2):115-8. doi: 10.1097/00002508-200106000-00003. PMID: 11444712. 31 Shrinivas.t.r, Kumar R, Comparative Evaluation Of Efficacy of EMLA Cream and a Placebo (Normal Saline) in producing dermal analgesia for venous cannulation. Indian J Clin Anaesth 2015;2(1):27-31 Van Damme S, Crombez G, Nieuwenborgh Van De Wever K, Goubert L. Is distraction less effective when pain is threatening? An experimental investigation with the cold pressor task. European Journal of Pain [Internet]. 2008 Jan 1;12(1):60–7. Available from: https://www.sciencedirect.com/science/article/pii/S1090380107000468 Sinha, M., Christopher, N. C., Fenn, R., & Reeves, L. (2006). Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics, 117(4), 1162–1168.https://doi.org/10.1542/peds.2005-1100 Stoltz P, Manworren RCB. Comparison of children's venipuncture fear and pain: Randomized controlled trial of EMLA and J-Tip needleless injection system. J Pediatr Nurs. 2017;37:16-22. Shahid R, Benedict C, Mishra S, Mulye M, Guo R. Using iPads for Distraction to Reduce Pain During Immunizations. Clinical Pediatrics [Internet]. 2015 Feb 1;54(2):145–8. Available from: https://pubmed.ncbi.nlm.nih.gov/25165071/ Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694. PMID: 32440065; PMCID: PMC7229378. Thomas A, Unnikrishnan DT, Mathai I. Comparison of Animation Distraction Versus Local Anesthetic Application for Pain Alleviation in Children Undergoing Intravenous Cannulation: A Randomized Controlled Trial. Cureus . 2023 Aug 1;15. Available from https://assets.cureus.com/uploads/original_article/pdf/165028/20230817-12765- 1kw2nyi.pdf Inal S, Canbulat N. Using of Distraction Methods on Procedural Pain Management of Pediatric Patients. Güncel Pediatri 2015 Sep 1;13(2):116–21. Available from: https://dergipark.org.tr/en/download/article-file/903699 Gates M, Hartling L, Shulhan-Kilroy J, MacGregor T, Guitard S, Wingert A, Featherstone R, Vandermeer B, Poonai N, Kircher J, Perry S, Graham TAD, Scott SD, Ali S. Digital Technology Distraction for Acute Pain in Children: A Meta- analysis. Pediatrics. 2020 Feb;145(2):e20191139. doi: 10.1542/peds.2019-1139. Epub 2020 Jan 22. PMID: 31969473. McMurtry CM. Needle and dread: Is it just a little poke? A call for implementation of evidence-based policies for the management of needle pain in clinical settings. Paediatr Child Health 2007;12(2):101-102 Young SS, Schwartz R, Sheridan MJ. EMLA cream as a topical anesthetic before office phlebotomy in children. Southern Medical Journal 1996 Dec 1;89(12):1184–7. Available from: https://pubmed.ncbi.nlm.nih.gov/8969353/ Yıldırım BG, Gerçeker GÖ. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. Journal of Emergency Nursing 2022;49:62–74. Des Jarlais DC, Lyles C, Crepaz N, Trend Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361-366. Robieux I, Eliopoulos C, Hwang PA, Greenberg MT, Blanchette VS, Olivieri NF, et al. Pain perception and effectiveness of the eutectic mixture of local anesthetics in children undergoing venipuncture. Pediatric Research [Internet]. 1992 Nov 1;32(5):520–3. Available from: https://www.nature.com/articles/pr1992279 Lander JR, Hodgins MJ, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain [Internet]. 1996 Jan 1;64(1):89–97. Available from: https://pubmed.ncbi.nlm.nih.gov/8867250/ Morgan-Hughes NJ, Kirton CB. EMLA--is one hour long enough? Anaesthesia [Internet]. 2001 May 2;56(5):495–6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/11350358 Fetzer SJ. Reducing venipuncture and intravenous insertion pain with eutectic mixture of local anesthetic: a meta-analysis. Nursing Research [Internet]. 2002 Mar 1;51(2):119–24. Available from: https://www.ncbi.nlm.nih.gov/books/NBK69364/ Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 05 Jan, 2026 Reviews received at journal 05 Jan, 2026 Reviewers agreed at journal 24 Dec, 2025 Reviewers agreed at journal 18 Dec, 2025 Reviews received at journal 18 Dec, 2025 Reviewers agreed at journal 18 Dec, 2025 Reviewers invited by journal 18 Dec, 2025 Editor invited by journal 27 Nov, 2025 Editor assigned by journal 26 Nov, 2025 Submission checks completed at journal 26 Nov, 2025 First submitted to journal 24 Nov, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8193507","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":562759089,"identity":"40d37019-d698-4c02-a53f-a91603060eef","order_by":0,"name":"Neha Thakur Rai","email":"","orcid":"","institution":"Dr Ram Manohar Lohia Institute of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Neha","middleName":"Thakur","lastName":"Rai","suffix":""},{"id":562759091,"identity":"b1bf47d2-b053-4ff9-9936-34d6eacd1c60","order_by":1,"name":"Shruti Jain","email":"","orcid":"","institution":"Dr Ram Manohar Lohia Institute of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Shruti","middleName":"","lastName":"Jain","suffix":""},{"id":562759093,"identity":"e77d4206-0f25-43be-85e5-1b18ac593213","order_by":2,"name":"Aaditya Katyal","email":"data:image/png;base64,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","orcid":"","institution":"Kasturba Medical College, Manipal, Manipal Academy of Higher Education (MAHE)","correspondingAuthor":true,"prefix":"","firstName":"Aaditya","middleName":"","lastName":"Katyal","suffix":""}],"badges":[],"createdAt":"2025-11-24 12:38:34","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8193507/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8193507/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":99307298,"identity":"4d13400f-32cd-4456-a1ac-f36019bbd027","added_by":"auto","created_at":"2025-12-31 16:05:56","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":593201,"visible":true,"origin":"","legend":"","description":"","filename":"EasingtheSting.docx","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/d9f9c9c4b81bf63c580d6ccd.docx"},{"id":98820723,"identity":"3defec37-1fc8-47b6-9dcf-5c9db98dfc1a","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":7331,"visible":true,"origin":"","legend":"","description":"","filename":"6b8781c4871547249108fcc55de3ce6d.json","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/8a9eb82a131f3ef798544f16.json"},{"id":98820728,"identity":"f2aad368-e07d-43f5-b134-5fb274c6bb96","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":102106,"visible":true,"origin":"","legend":"","description":"","filename":"6b8781c4871547249108fcc55de3ce6d1enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/9bde6a8bd901382fa0fb4690.xml"},{"id":98820725,"identity":"57948877-fafd-49e9-a026-6aeb3234e72e","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"png","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":202588,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/8eea0b0eca876e6884182b5b.png"},{"id":98820732,"identity":"b5d7e3d0-26ca-4b99-8d3f-90680d1c858f","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"png","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":335616,"visible":true,"origin":"","legend":"","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/53ed07ab199b9d38e9ea6cfc.png"},{"id":99307439,"identity":"36c67da7-59f6-40a1-baaa-85874814e2ae","added_by":"auto","created_at":"2025-12-31 16:06:15","extension":"png","order_by":5,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":36629,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/cffa883f9a39e9b09afd6c71.png"},{"id":99307424,"identity":"93baaf75-100e-483f-a814-5577e8f4dc17","added_by":"auto","created_at":"2025-12-31 16:06:14","extension":"png","order_by":6,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":37292,"visible":true,"origin":"","legend":"","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/db63f179eb898be5b693efa1.png"},{"id":98820731,"identity":"c04f1f5f-44e1-4774-974e-c54f4dceceef","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"xml","order_by":7,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":99622,"visible":true,"origin":"","legend":"","description":"","filename":"6b8781c4871547249108fcc55de3ce6d1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/79e50654b4d02cdd09d623ef.xml"},{"id":98820733,"identity":"46359a11-d5f9-4dbd-8d44-5dc8080b76ec","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"html","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":113130,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/d50d0af2e3b56993fdce7c61.html"},{"id":98820724,"identity":"2f177b43-0df0-44b0-9153-79fd0b3163a2","added_by":"auto","created_at":"2025-12-22 17:17:53","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":202588,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStudy flow diagram.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/19116b201a2128aab33cb3af.png"},{"id":99307289,"identity":"354be39b-9990-4a0d-a2b6-93bd624eed2d","added_by":"auto","created_at":"2025-12-31 16:05:54","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":335616,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMean Wong–Baker FACES pain scores over time for Digital Distraction versus EMLA cream during pediatric IV cannulation.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/f7ee38c10bf0c92cd4d5a017.png"},{"id":99788096,"identity":"7a547aa7-1401-4781-9f3a-0d473abee3ba","added_by":"auto","created_at":"2026-01-08 12:44:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1725013,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8193507/v1/1dd7ce80-a4e9-429d-967f-41caeb4acbcd.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Easing the Sting: A Paired Crossover Study Comparing Pain Relief with EMLA Cream vs Digital Distraction During Pediatric IV Cannulation","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eEffective management of procedural pain is a critical yet often overlooked component of pediatric healthcare. Needle-related procedures such as venipuncture and intravenous (IV) cannulation are among the most frequent sources of acute pain for children, and inadequately treated pain can have lasting physiological and psychological consequences. Stevens highlights that pain in children is a multidimensional experience involving emotional, cognitive, and behavioral domains, highlighting the need for comprehensive management strategies [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Despite this, pediatric pain is frequently underestimated and undertreated, as emphasized by the American Academy of Pediatrics (AAP), which calls for structured pain assessment and timely analgesic interventions for infants and children undergoing invasive procedures [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTopical anesthetics such as the Eutectic Mixture of Local Anesthetics (EMLA) cream have been widely used to reduce procedural pain. Evidence from several clinical studies and reviews indicates that EMLA effectively decreases discomfort associated with venipuncture and IV catheter placement in pediatric patients [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Its analgesic effect and safety profile make it a standard option in many pediatric units. However, EMLA requires 45\u0026ndash;60 minutes to achieve sufficient dermal anesthesia, and its availability and cost can limit use in high-volume or resource-constrained settings typical of low- and middle-income countries (LMICs). These limitations highlight the need for practical, rapidly deployable alternatives.\u003c/p\u003e \u003cp\u003eDigital Distraction (DD) represents a non-pharmacological alternative grounded in attentional control theory, which posits that directing cognitive resources toward immersive visual and auditory stimuli reduces the perceptual salience of painful input. Age-appropriate animated videos act by capturing and sustaining the child\u0026rsquo;s attentional bandwidth, thereby modulating pain interpretation at the cortical level. Prior studies demonstrate that distraction reduces both perceived pain and distress in children undergoing medical procedures such as laceration repair and immunization [\u003cspan additionalcitationids=\"CR7 CR8 CR9 CR10 CR11\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Digital technology\u0026ndash;based distraction has shown encouraging results; a recent meta-analysis reported that digital tools significantly reduce acute procedural pain in children, supporting their role in modern pediatric pain protocols [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eNonetheless, key gaps remain. First, although both EMLA and Digital Distraction (DD) have shown individual efficacy, direct head-to-head comparisons within the same pediatric population are scarce, especially in LMIC settings where decisions must consider feasibility, cost, and time constraints. Second, prior studies often differ in methodology, content used for distraction, and pain assessment strategies, making cross-study comparisons challenging. Third, as highlighted by previous authors, the subjective nature of pain scoring introduces potential inter- and intra-observer variability, necessitating careful design to minimize bias [\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite evidence supporting both modalities independently, direct comparative data between EMLA and standardized Digital Distraction during pediatric IV cannulation are limited, particularly in the Indian context. Many distraction studies also use heterogeneous content, making comparisons difficult. Given known inter-individual variability in pain perception and coping styles among children, a crossover design\u0026mdash;in which each child receives both interventions\u0026mdash;allows for more precise within-subject comparison by minimizing baseline variability.\u003c/p\u003e \u003cp\u003eGiven these considerations, the present study was conducted to address the lack of direct comparative evidence between EMLA cream and DD in pediatric IV cannulation. The primary objective was to compare procedural pain at 0, 1 and 3 minutes post-cannulation using the Wong\u0026ndash;Baker FACES Pain Rating Scale (WBFPS) among children aged 5\u0026ndash;12 years who experienced both interventions in a quasi-experimental crossover design. In accordance with attentional and pharmacologic mechanistic principles, we established a 1-point non-inferiority margin to evaluate whether Digital Distraction could match the analgesic performance of EMLA.\u003c/p\u003e \u003cp\u003eBy comparing a pharmacologic analgesic with a feasible digital distraction strategy within the same cohort of children, this study aims to provide practical, contextually relevant evidence for improving pediatric procedural pain management in resource-limited clinical environments.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis quasi-experimental, non-randomized crossover trial was conducted over a period of one year in the Department of Pediatrics at a tertiary care teaching hospital in Northern India and reported in accordance with the TREND guidelines [17]. The study evaluated whether Digital Distraction (DD) was non-inferior to EMLA cream in reducing procedural pain during intravenous (IV) cannulation in children aged 5\u0026ndash;12 years. Ethical clearance was obtained from the Institutional Ethics Committee (IEC No. RC-791-22-06-2023).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants and Eligibility\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChildren aged \u003cstrong\u003e5\u0026ndash;12 years\u003c/strong\u003e who required \u003cstrong\u003etwo clinically indicated IV cannulations\u003c/strong\u003e during their admission were screened. Eligibility criteria included: being conscious, clinically stable, able to self-report pain, and not receiving sedatives, anticonvulsants, or systemic analgesics at the time of the procedure. Exclusion criteria included audio-visual impairment, dermatologic abnormalities at the cannulation site, known hypersensitivity to lidocaine\u0026ndash;prilocaine, or significant hepatic, renal, or cardiac disease.\u003c/p\u003e\n\u003cp\u003eParticipants were recruited using \u003cstrong\u003econsecutive sampling\u003c/strong\u003e from the Pediatric Care Unit, Emergency, and general pediatric wards. Written informed consent was obtained from parents or legal guardians, and assent was obtained from children aged \u0026ge;7 years.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample Size Calculation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size was determined a priori using a non-inferiority framework. Calculations were based on data from Yıldırım et al. (2013), who compared virtual reality (VR) distraction with standard care in children undergoing painful procedures [16]. In that study, the VR distraction group had a mean WBFPS score of 5.6 \u0026plusmn; 1.9, while the control group had a mean of 6.2 \u0026plusmn; 1.0. Using a two-sided alpha of 0.05, 90% power, an allocation ratio of 1:1, and a clinically meaningful non-inferiority margin of 10% (equivalent to 0.6 points on the WBFPS scale), the minimum required sample size was 68 children per group (136 total). Accounting for 10% attrition, the final sample size target was 150, and 161 children completed both phases.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAssignment to receive EMLA first or digital distraction (DD) first was based on parental preference after a detailed explanation of both interventions. The study used a paired crossover design in which every child received both interventions during two separate cannulation attempts, allowing each participant to serve as their own control. Some children received EMLA before the first cannulation and DD during the second, while others received the reverse sequence. The second cannulation occurred later during the hospital stay, which helped control for individual variations in baseline pain tolerance and familiarity with the procedure.\u003c/p\u003e\n\u003cp\u003eEMLA cream, a eutectic mixture containing 2.5% lidocaine and 2.5% prilocaine, was applied at a dose of roughly 1 g per 10 cm\u0026sup2;, with a maximum of 2 g per site in accordance with pediatric FDA recommendations. Older children (7\u0026ndash;12 years, weighing more than 20 kg) could receive up to 20 g over 200 cm\u0026sup2; for up to four hours. The cream was applied 45\u0026ndash;60 minutes before cannulation under an occlusive dressing, and the skin was examined on removal for erythema, edema, or other local reactions.\u003c/p\u003e\n\u003cp\u003eDigital distraction consisted of a standardized set of preloaded, offline animated cartoon videos selected for age appropriateness and visual engagement. These videos were shown beginning 10\u0026ndash;15 minutes before cannulation, continued throughout the procedure, and extended for three minutes afterward. The device was positioned in the child\u0026rsquo;s direct line of sight, and adherence to the distraction protocol was ensured by a trained staff member or simulation technician.\u003c/p\u003e\n\u003cp\u003eEach child formed the unit of delivery and analysis, and interventions were administered individually with no cluster effects. Fidelity was maintained through preloaded uniform content, fixed viewing angles, and the absence of co-interventions.\u003c/p\u003e\n\u003cp\u003eThe study aimed to compare procedural pain between EMLA and DD, evaluating whether DD was non-inferior to EMLA within a one-point margin on the Wong\u0026ndash;Baker FACES Pain Rating Scale (WBFPS). Pain was assessed at 0, 1, and 3 minutes after cannulation by a trained independent assessor who was blinded to intervention identity through the use of coded, audio-free video recordings. Because the nature of the interventions made participant and clinician blinding impossible, outcome blinding was strictly preserved.\u003c/p\u003e\n\u003cp\u003ePain scores were non-normally distributed based on Shapiro\u0026ndash;Wilk testing. Paired differences between interventions at each time point were analyzed with the Wilcoxon signed-rank test. Prespecified subgroup analyses examined effects of prior painful experiences, cannulation site and cannula gauge. No imputation was required because all participants completed both phases. Analyses were performed using IBM SPSS version 21, with statistical significance set at p \u0026le; 0.05, and a predefined non-inferiority margin of 10% to represent a clinically meaningful difference in pain scores.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of \u003cstrong\u003e204 children\u003c/strong\u003e were screened for eligibility, of whom \u003cstrong\u003e43\u003c/strong\u003e were excluded (27 did not meet inclusion criteria, 12 declined participation, and 4 were unable to complete the protocol for logistical reasons). The remaining \u003cstrong\u003e161 children\u003c/strong\u003e were enrolled, provided assent/consent, and completed \u003cstrong\u003eboth intervention phases\u003c/strong\u003e without loss to follow-up or protocol deviations. Of these, \u003cstrong\u003e68\u003c/strong\u003e children received \u003cstrong\u003eEMLA first\u003c/strong\u003e, and \u003cstrong\u003e93\u003c/strong\u003e received \u003cstrong\u003eDigital Distraction first\u003c/strong\u003e, in accordance with parental preference for the initial procedure. All participants subsequently crossed over to the alternate intervention at the second clinically indicated cannulation, resulting in \u003cstrong\u003epaired data\u003c/strong\u003e for all children (Fig 1).\u003c/p\u003e\n\u003cp\u003eRecruitment occurred between \u003cstrong\u003eJuly 2023 and June 2024\u003c/strong\u003e. Baseline demographic and clinical characteristics are summarised in Table 1. The two initial sequence groups\u0026mdash;those receiving EMLA first (Sequence A) and those receiving Digital Distraction first (Sequence B)\u0026mdash;were comparable across all key variables, including age, sex distribution, prior venepuncture exposure, underlying comorbidities, cannulation site, and cannula gauge. As all enrolled children completed both intervention phases, no further comparisons between retained and lost participants were necessary.\u003c/p\u003e\n\u003cp\u003eNo adverse effects or unintended events (e.g., erythema, edema, hypersensitivity) were observed in either intervention phase.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1: Baseline characteristics of the study population (n = 161).\u003c/strong\u003e\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"661\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 548px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariables\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en=161(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge Group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 312px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003e5-8 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" rowspan=\"5\" valign=\"top\" style=\"width: 312px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 97 \u0026nbsp;(60.2)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;64 (39.8)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 100 \u0026nbsp;(62.1)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 61 \u0026nbsp;(37.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003e9-12 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSex\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious venepuncture experience\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026lt;5 times\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e89 (55.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e6 To 10 times\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e42 (26.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026gt;10 times\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e30 (18.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious episode of any painful medical procedure besides IV cannulation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e134 (83.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e27 (16.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious hospitalization\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e97 (60.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e64 (39.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e144 (89.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e17 (10.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePre-existing skin conditions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e118 (73.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e43 (26.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eDevelopmental milestones\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eAppropriate for age\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e156 (96.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eDelayed for age\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e5 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eCongenital abnormalities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e157 (97.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e4 (2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eSite of I.V. cannulation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eDorsum of hand\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e115 (71.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eForearm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e36 (22.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e10 (6.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eSize of cannula \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e24 Gauge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e109 (67.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e22 Gauge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e48 (29.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e20 Gauge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e4 (2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eImmunization\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUp to date\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e139 (86.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003ePartially immunized till date\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e21 (13)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUnimmunized till date\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e1 (0.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eAdmission at birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e136 (84.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e25 (15.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious history of illness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e82 (50.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e79 (49.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eDocumented allergies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e136 (84.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e25 (15.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eFirst cannulation done with\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eDigital Distraction\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e93 (57.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eEMLA cream\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e68 (42.24)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003eDuration of hospital stay\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e2-6 days\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e74 (46)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e7-11 days\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e55 (34.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e12-16 days\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e17 (10.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eMore than 16 days\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e15 (9.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 349px;\"\u003e\n \u003cp\u003ePrevious blood sampling experience\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e2 to 5 times in a week\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e102 (63.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e6 to 9 times in a week\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e52 (32.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e10 to 12 times in a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e7 (4.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003ePaired comparisons demonstrated that EMLA consistently resulted in significantly lower pain scores than Digital Distraction at all measured timepoints. At 0 minutes, immediately after cannulation, both interventions showed an expected rise from baseline; however, the rise was significantly smaller under EMLA (Wilcoxon Z = \u0026ndash;10.567, p \u0026lt; 0.001) compared with DD (Z = \u0026ndash;11.36, p \u0026lt; 0.001). The median paired difference exceeded the predefined 1-point non-inferiority margin, indicating that DD was not non-inferior to EMLA at peak procedural pain.\u003c/p\u003e\n\u003cp\u003eAt 1 minute, pain had begun to decline in both conditions, but remained significantly lower with EMLA (Z = \u0026ndash;7.576, p \u0026lt; 0.001) than with DD (Z = \u0026ndash;10.315, p \u0026lt; 0.001). By 3 minutes, pain continued to fall, with EMLA again demonstrating a more favorable trajectory (Z = \u0026ndash;1.126, p \u0026lt; 0.001) compared with DD (Z = \u0026ndash;6.588, p \u0026lt; 0.001). Across all intervals, the observed paired differences exceeded the non-inferiority limit, confirming that Digital Distraction was not non-inferior to EMLA for procedural analgesia.\u003c/p\u003e\n\u003cp\u003eWithin each intervention, pain decreased significantly over time. The reduction from 0\u0026rarr;1 minute and 0\u0026rarr;3 minutes was significant in both groups, but the magnitude of decline was greater and more consistent with EMLA, indicating a more stable analgesic effect (Table 2, Figure 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: Paired comparison of pain scores (WBFPS) between Digital Distraction and EMLA at each time point.\u003c/strong\u003e\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"73%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" rowspan=\"2\" valign=\"bottom\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime Interval\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 46px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWong Baker FACES Pain Scale\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEMLA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"bottom\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre insertion to 0 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean pre\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e4(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 0\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-11.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-10.567\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre insertion to 1 minutes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean pre\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e4(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-10.315\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-7.576\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre insertion to 3 minutes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean pre\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e4(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-6.588\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-1.126\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 to 1 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-6.48\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-8.088\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 to 3 minutes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 3\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-10.603\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-11.953\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 to 3 minutes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean 3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWilcoxon\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e-9.296\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e-9.015\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 25px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eSubgroup Analyses\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eA. Previous painful experiences\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eChildren with and without prior painful procedures showed similar patterns: EMLA consistently produced lower pain scores across all time points. Prior procedural exposure did not significantly modify the comparative effectiveness (Table 3A).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eB. Cannulation site\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePain intensity varied by site, with procedures on the dorsum of the hand generally producing higher discomfort. Even in these more painful sites, EMLA outperformed DD across all time points, with statistically significant differences particularly evident at 1 minute post-insertion (Table 3B).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eC. Cannula gauge\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePain tended to be higher with larger-gauge cannulas (20G \u0026gt; 22G \u0026gt; 24G). Across all gauge sizes, EMLA continued to yield more favorable pain profiles. Significant differences were observed particularly for 20-gauge cannulations, where EMLA demonstrated considerably superior analgesia (Table 3C).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTABLE 3: Subgroup analysis of procedural pain scores (DD vs. EMLA)\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 29px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime stamp\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre-insertion\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 minute\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 16px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003eGroup\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18px;\"\u003e\n \u003cp\u003e\u003cem\u003eOther previous painful medical procedures\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"10\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eA. WBFPS scores over time for Digital Distraction vs. EMLA cream in children with vs. without previous painful medical procedures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 10px;\"\u003e\n \u003cp\u003eDD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(1,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.594\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e3(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.432\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e3(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.293\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(1,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.888\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 18px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(2,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e3(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(1,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 10px;\"\u003e\n \u003cp\u003eEC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 18px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e3(2,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.573\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e4(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.455\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e4(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 8px;\"\u003e\n \u003cp\u003e0.424\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e3(2,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 7px;\"\u003e\n \u003cp\u003e0.318\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 18px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e3(2,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e3(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(2,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 8px;\"\u003e\n \u003cp\u003e2(2,3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"left\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"10\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eB. WBFPS scores over time for Digital Distraction vs. EMLA cream by IV cannulation site (dorsum of hand, forearm, or other)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 7px;\"\u003e\n \u003cp\u003eDD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eDorsum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e4(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.009*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.064\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.038*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.110\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eForearm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(8,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(6.5,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e6(6,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e3(2,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e7(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e6(2,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e5(2,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 7px;\"\u003e\n \u003cp\u003eEC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eDorsum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.054\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.356\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.243\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.200\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eForearm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(6,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(8,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e6(6,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e4(2,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e6(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e7(2,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003e5(2,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"10\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eC. WBFPS scores over time for Digital Distraction vs. EMLA cream by IV cannula size (20 vs. 22 vs. 24 gauge).\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime stamp\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 23px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre-insertion\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 minute\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 minutes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 6px;\"\u003e\n \u003cp\u003eGroup\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 9px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 6px;\"\u003e\n \u003cp\u003eDD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e7(4.5,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 11px;\"\u003e\n \u003cp\u003e0.080\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e10(8.5,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.006\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e10(8.5,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e7(6,9.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.057\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e4(2,6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e6(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e6(2,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e4(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" style=\"width: 6px;\"\u003e\n \u003cp\u003eEC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e6(4.5,7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 11px;\"\u003e\n \u003cp\u003e0.059\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e9(8,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.018\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e9(8,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.005\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e7(4.5,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.084\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e6(2.5,7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e7(6,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e6(4,6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 7px;\"\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e8(6,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 10px;\"\u003e\n \u003cp\u003e8(4,10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 11px;\"\u003e\n \u003cp\u003e6(4,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis quasi-experimental crossover study compared the effectiveness of Digital Distraction (DD) and EMLA cream in reducing procedural pain during intravenous cannulation among children aged 5\u0026ndash;12 years. The findings demonstrate that EMLA provided consistently superior pain relief across all measured intervals, while DD offered partial but insufficient analgesia to meet the predefined non-inferiority criterion. These findings are consistent with the proposed mechanisms of the interventions: EMLA exerts a pharmacologic dermal anesthetic effect, reducing nociceptive afferent signals at the site of needle insertion, whereas Digital Distraction relies on attentional shift\u0026mdash;redirecting cognitive resources away from the painful stimulus through visual and auditory engagement. Although DD successfully lowered pain relative to baseline, it did not adequately attenuate the peak nociceptive response, which is better addressed by a pharmacological agent.\u003c/p\u003e \u003cp\u003eThe superiority of EMLA observed in this study is well supported by existing literature. Cordoni and Cordoni reported significant reductions in cannulation pain with EMLA [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], while Shrinivas and Kumar similarly demonstrated that topical anesthesia provides superior dermal analgesia compared with placebo [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Young et al. observed that EMLA applied before phlebotomy significantly improved pain tolerance [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], and Robieux et al. highlighted its clear benefit in reducing pain perception in pediatric venipuncture [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. These previous findings confirm that EMLA reliably minimizes nociceptive input during needle procedures and directly align with the pain trajectories observed in our population.\u003c/p\u003e \u003cp\u003eDigital distraction, although not non-inferior to EMLA, did reduce the rise in pain from baseline and showed a consistent downward trend in pain scores over time. This aligns with prior evidence demonstrating partial analgesic benefit with distraction. Sinha et al. found that distraction reduced distress during laceration repair [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], and Shahid et al. showed that distraction through iPads lowered pain during immunization [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Rao et al. similarly reported reductions in pain with virtual reality distraction [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. These findings collectively support the role of DD as a helpful adjunctive modality based on attentional diversion. Furthermore, earlier work investigating distraction techniques has shown that while they can reduce distress and perceived discomfort, their effectiveness varies depending on the child\u0026rsquo;s engagement, the intensity of the painful stimulus, and the distraction content. Our standardized DD protocol minimized variability in content\u0026mdash;a limitation often noted in distraction studies\u0026mdash;yet the analgesic effect remained modest compared with EMLA. The attentional control theory underlying distraction posits that competing sensory input reduces cognitive capacity available for pain processing; however, during high-intensity, rapid-onset stimuli such as needle insertion, the efficacy of distraction appears limited. The work of Gates et al., which found significant variability in distraction-related analgesia across studies, further contextualizes why DD did not achieve non-inferiority [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe temporal profile of pain in this study also reinforces known physiological mechanisms. Pain peaked immediately after insertion for both interventions, reflecting the sharp nociceptive impact of skin penetration. However, pain declined more rapidly and consistently in the EMLA phase, demonstrating the sustained dermal blockade provided by the anesthetic mixture. This pattern is consistent with previous findings indicating that distraction is less effective when pain is intense or perceived as threatening, as highlighted by Van Damme et al. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAn important strength of this study is its crossover design, which allowed each child to serve as their own control. This reduces potential confounding arising from inter-individual differences in pain threshold, prior medical experiences, temperament, and coping strategies\u0026mdash;factors that are especially relevant in pediatric behavioral research. The use of a blinded independent assessor reviewing video-recorded facial expressions further minimized observer bias. Additionally, the standardized distraction content and consistent procedural workflow improved fidelity and ensured that differences in performance were attributable to the interventions rather than contextual inconsistencies.\u003c/p\u003e \u003cp\u003eSubgroup analyses reinforced the overall findings. EMLA maintained superior analgesia across cannulation sites, cannula gauges, and among children with or without previous painful medical experiences. Even in inherently more painful scenarios \u0026mdash; such as dorsal hand cannulations or use of larger-gauge cannulas \u0026mdash; EMLA demonstrated better pain control, proving its reliability across procedural contexts. These observations are consistent with earlier literature demonstrating the reproducibility of EMLA\u0026rsquo;s analgesic effects across varied clinical situations [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite these strengths, several potential sources of bias must be considered. First, the study employed non-randomized allocation based on parental preference, introducing the possibility of selection bias. Although the paired crossover design mitigated this risk, the initial assignment could still reflect parental expectations or child temperament. Second, participants and intervention deliverers were not blinded due to practical constraints inherent to behavioral and topical interventions. Third, as with all self-report pain scales, subjective interpretation remains a limitation despite using a validated tool and blinded scoring. Fourth, the absence of a formal washout period between interventions could theoretically result in carryover effects, although the natural clinical spacing between cannulations likely minimized this risk. Finally, the distraction effect may vary depending on the individual child\u0026rsquo;s preferences, interest level, or familiarity with digital media; while standardized content reduces variability, it cannot eliminate individual differences in engagement.\u003c/p\u003e \u003cp\u003eImplementation fidelity was high, but practical barriers observed during workflow\u0026mdash;such as maintaining device placement within the child\u0026rsquo;s line of sight or ensuring continuous engagement\u0026mdash;highlight the challenges of integrating distraction consistently in dynamic clinical settings. In contrast, EMLA use requires preparation time and may not always be feasible in fast-paced emergency units. As noted by Gates et al., distraction techniques can be valuable in such environments when implemented consistently [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. These contextual factors are important for interpreting real-world applicability.\u003c/p\u003e \u003cp\u003eThe findings carry pragmatic implications for pediatric procedural pain management, particularly in resource-limited settings. While EMLA remains the superior analgesic, its cost, availability, and required application time may limit routine use in high-volume pediatric units. Digital Distraction, despite not meeting non-inferiority criteria, demonstrated meaningful pain reduction relative to baseline and remains an accessible, low-cost adjunct that can enhance the overall procedural experience, especially where topical anesthetics cannot be used. Given that distraction has broader benefits in reducing anxiety and improving cooperation, it may still serve as an important supportive measure alongside pharmacological analgesia.\u003c/p\u003e \u003cp\u003eGeneralizability of these findings is strengthened by the pragmatic design, real-world clinical setting, and inclusion of a broad pediatric age range typical of cannulation scenarios. However, external validity may be influenced by local factors such as staff expertise, patient demographics, caregiver expectations, and availability of digital tools. Further studies could explore combined approaches\u0026mdash;EMLA plus DD\u0026mdash;and evaluate the additive benefits for child comfort and cooperation.\u003c/p\u003e \u003cp\u003eIn conclusion, this study demonstrates that EMLA cream provides superior analgesia at all measured intervals during pediatric intravenous cannulation, while Digital Distraction offers modest but meaningful reductions in pain. DD did not achieve non-inferiority and should therefore be considered an adjunct rather than a substitute for topical anesthesia. In settings where EMLA application is not possible, Digital Distraction remains a valuable, accessible alternative capable of enhancing the child\u0026rsquo;s overall experience. The methodological rigor, crossover design, standardized distraction protocol, and blinded assessment contribute to the reliability of the findings. Together, these findings support a multimodal approach to optimizing pediatric procedural comfort, particularly in resource-limited environments where balancing feasibility and analgesic efficacy is essential.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch3\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eAll study procedures were performed in accordance with the ethical standards of the institutional research committee, the Indian Council of Medical Research (ICMR) guidelines, and the Declaration of Helsinki. Ethical approval for the study was obtained from the\u0026nbsp;\u003cstrong\u003eInstitutional Ethics Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow\u003c/strong\u003e (IEC No.\u0026nbsp;\u003cstrong\u003eRC-791-22-06-2023\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from parents or legal guardians of all participating children, and assent was obtained from children aged 7 years and above.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eNo identifiable images, videos, or personal details of participants are included in this manuscript. All data were fully anonymized before analysis. As per institutional guidelines, separate consent for publication was not required. Documentation from the ethics committee can be provided upon request.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eAll data generated and analyzed during this study are included in this published article and its associated tables and figures. Additional supporting material or anonymized datasets are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eThe authors declare that they have\u0026nbsp;\u003cstrong\u003eno competing interests\u003c/strong\u003e\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eThis research received\u0026nbsp;\u003cstrong\u003eno external funding\u003c/strong\u003e. No financial support or grants were obtained for conducting the study or preparing the manuscript.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003eNTR\u003c/strong\u003e, \u003cstrong\u003eand SJ\u003c/strong\u003e conceptualized the study and developed the study design. \u003cstrong\u003eSJ\u003c/strong\u003e led protocol development, prepared the data collection forms, coordinated recruitment, while NTR supervised day-to-day conduct of the study. \u003cstrong\u003eNTR\u003c/strong\u003e performed the preliminary data cleaning and organisation, assisted by \u003cstrong\u003eSJ\u003c/strong\u003e, who also managed the video-based scoring workflow and ensured blinding procedures were maintained.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAK\u003c/strong\u003e contributed in refining the study methodology, developing the statistical analysis plan, and conducting the final analyses. He supported interpretation of findings, drafted major portions of the manuscript, integrated reviewer-directed revisions, and prepared the final submission-ready version.\u003c/p\u003e\n\u003cp\u003eAll authors participated in manuscript writing, critically reviewed all drafts for intellectual content, approved the final version, and agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eThe authors gratefully acknowledge the support of the\u0026nbsp;\u003cstrong\u003eDepartment of Pediatrics, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow\u003c/strong\u003e, and the nursing staff whose cooperation made this study possible. The authors also appreciate the guidance provided by the clinical and administrative teams throughout the study period.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003eAuthors\u0026rsquo; information\u003c/strong\u003e\u003c/h3\u003e\n\u003col\u003e\n \u003cli\u003e\u003cstrong\u003eDepartment of Pediatrics\u003c/strong\u003e, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eDepartment of Emergency Medicine\u003c/strong\u003e, Kasturba Medical College, Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eStevens B. Revisions to the IASP definition of pain-What does this mean for children? Paediatr Neonatal Pain. 2021 Mar 27;3(3):101-105. doi: 10.1002/pne2.12047. PMID: 35547949; PMCID: PMC8975187.\u003c/li\u003e\n\u003cli\u003eAmerican Academy of Pediatrics. Committee on Psychosocial Aspects of Child and Family Health; Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001 Sep;108(3):793-7. doi: 10.1542/peds.108.3.793. PMID: 11533354.\u003c/li\u003e\n\u003cli\u003eCurtis S, Wingert A, Ali S. The Cochrane Library and Procedural Pain in Children: An Overview of Reviews. Evidence-based Child Health: A Cochrane Review Journal [Internet]. 2008 Jun 1;7(5):1363\u0026ndash;99. Available from: http://onlinelibrary.wiley.com/doi/10.1002/ebch.1864/full \u003c/li\u003e\n\u003cli\u003eCordoni A, Cordoni LE. Eutectic mixture of local anaesthetics reduces pain during intravenous catheter insertion in the pediatric patient. Clin J Pain. 2001 Jun;17(2):115-8. doi: 10.1097/00002508-200106000-00003. PMID: 11444712. 31 \u003c/li\u003e\n\u003cli\u003eShrinivas.t.r, Kumar R, Comparative Evaluation Of Efficacy of EMLA Cream and a Placebo (Normal Saline) in producing dermal analgesia for venous cannulation. Indian J Clin Anaesth 2015;2(1):27-31 \u003c/li\u003e\n\u003cli\u003eVan Damme S, Crombez G, Nieuwenborgh Van De Wever K, Goubert L. Is distraction less effective when pain is threatening? An experimental investigation with the cold pressor task. European Journal of Pain [Internet]. 2008 Jan 1;12(1):60\u0026ndash;7. Available from: https://www.sciencedirect.com/science/article/pii/S1090380107000468 \u003c/li\u003e\n\u003cli\u003eSinha, M., Christopher, N. C., Fenn, R., \u0026amp; Reeves, L. (2006). Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics, 117(4), 1162\u0026ndash;1168.https://doi.org/10.1542/peds.2005-1100\u003c/li\u003e\n\u003cli\u003eStoltz P, Manworren RCB. Comparison of children\u0026apos;s venipuncture fear and pain: Randomized controlled trial of EMLA and J-Tip needleless injection system. J Pediatr Nurs. 2017;37:16-22.\u003c/li\u003e\n\u003cli\u003eShahid R, Benedict C, Mishra S, Mulye M, Guo R. Using iPads for Distraction to Reduce Pain During Immunizations. Clinical Pediatrics [Internet]. 2015 Feb 1;54(2):145\u0026ndash;8. Available from: https://pubmed.ncbi.nlm.nih.gov/25165071/\u003c/li\u003e\n\u003cli\u003eRao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694. PMID: 32440065; PMCID: PMC7229378.\u003c/li\u003e\n\u003cli\u003eThomas A, Unnikrishnan DT, Mathai I. Comparison of Animation Distraction Versus Local Anesthetic Application for Pain Alleviation in Children Undergoing Intravenous Cannulation: A Randomized Controlled Trial. Cureus . 2023 Aug 1;15. Available from https://assets.cureus.com/uploads/original_article/pdf/165028/20230817-12765- 1kw2nyi.pdf \u003c/li\u003e\n\u003cli\u003eInal S, Canbulat N. Using of Distraction Methods on Procedural Pain Management of Pediatric Patients. Güncel Pediatri 2015 Sep 1;13(2):116\u0026ndash;21. Available from: https://dergipark.org.tr/en/download/article-file/903699 \u003c/li\u003e\n\u003cli\u003eGates M, Hartling L, Shulhan-Kilroy J, MacGregor T, Guitard S, Wingert A, Featherstone R, Vandermeer B, Poonai N, Kircher J, Perry S, Graham TAD, Scott SD, Ali S. Digital Technology Distraction for Acute Pain in Children: A Meta- analysis. Pediatrics. 2020 Feb;145(2):e20191139. doi: 10.1542/peds.2019-1139. Epub 2020 Jan 22. PMID: 31969473. \u003c/li\u003e\n\u003cli\u003eMcMurtry CM. Needle and dread: Is it just a little poke? A call for implementation of evidence-based policies for the management of needle pain in clinical settings. Paediatr Child Health 2007;12(2):101-102 \u003c/li\u003e\n\u003cli\u003eYoung SS, Schwartz R, Sheridan MJ. EMLA cream as a topical anesthetic before office phlebotomy in children. Southern Medical Journal 1996 Dec 1;89(12):1184\u0026ndash;7. Available from: https://pubmed.ncbi.nlm.nih.gov/8969353/ \u003c/li\u003e\n\u003cli\u003eYıldırım BG, Ger\u0026ccedil;eker G\u0026Ouml;. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. Journal of Emergency Nursing 2022;49:62\u0026ndash;74.\u003c/li\u003e\n\u003cli\u003eDes Jarlais DC, Lyles C, Crepaz N, Trend Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361-366.\u003c/li\u003e\n\u003cli\u003eRobieux I, Eliopoulos C, Hwang PA, Greenberg MT, Blanchette VS, Olivieri NF, et al. Pain perception and effectiveness of the eutectic mixture of local anesthetics in children undergoing venipuncture. Pediatric Research [Internet]. 1992 Nov 1;32(5):520\u0026ndash;3. Available from: https://www.nature.com/articles/pr1992279 \u003c/li\u003e\n\u003cli\u003eLander JR, Hodgins MJ, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain [Internet]. 1996 Jan 1;64(1):89\u0026ndash;97. Available from: https://pubmed.ncbi.nlm.nih.gov/8867250/ \u003c/li\u003e\n\u003cli\u003eMorgan-Hughes NJ, Kirton CB. EMLA--is one hour long enough? Anaesthesia [Internet]. 2001 May 2;56(5):495\u0026ndash;6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/11350358\u003c/li\u003e\n\u003cli\u003eFetzer SJ. Reducing venipuncture and intravenous insertion pain with eutectic mixture of local anesthetic: a meta-analysis. Nursing Research [Internet]. 2002 Mar 1;51(2):119\u0026ndash;24. Available from: https://www.ncbi.nlm.nih.gov/books/NBK69364/\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"pediatric pain, intravenous cannulation, EMLA, digital distraction, crossover study, procedural analgesia, TREND","lastPublishedDoi":"10.21203/rs.3.rs-8193507/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8193507/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eIntravenous (IV) cannulation is among the most common and distressing procedures in pediatric care. Eutectic Mixture of Local Anesthetics (EMLA) cream is a widely used pharmacological analgesic, while Digital Distraction (DD) is a feasible non-pharmacological strategy in low- and middle-income settings. However, high-quality comparative evidence\u0026mdash;particularly using a paired, crossover design\u0026mdash;is limited. This study compared the effectiveness of EMLA cream versus standardized digital distraction in reducing procedural pain during pediatric IV cannulation.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003e This quasi-experimental non-randomized paired crossover study, reported in accordance with the TREND guidelines, was conducted in the Pediatric Care Unit of a tertiary-care teaching hospital in Northern India. Children aged 5\u0026ndash;12 years requiring two IV cannulations were enrolled. Allocation of the first intervention was made based on parental preference, and each child subsequently crossed over to receive the alternate method at the next clinically indicated cannulation. EMLA was applied 45\u0026ndash;60 minutes before cannulation. DD consisted of standardized offline age-appropriate cartoon videos shown 10\u0026ndash;15 minutes before, during, and after cannulation. Pain was assessed at 0, 1, and 3 minutes post-insertion using the Wong\u0026ndash;Baker FACES Pain Rating Scale (WBFPS). Pain assessments were performed by a blinded independent observer scoring video-recorded facial expressions. Paired comparisons were analyzed using the Wilcoxon signed-rank test, with a 1-point non-inferiority margin which was defined a priori.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 161 children completed both intervention phases. Pain scores were consistently lower with EMLA at all three time points. Median paired differences favored EMLA at 0 minutes (EMLA: 8 [IQR 6\u0026ndash;10] vs. DD: 8 [\u003cspan additionalcitationids=\"CR7 CR8 CR9\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]), 1 minute (EMLA: 8 [\u003cspan additionalcitationids=\"CR5 CR6 CR7 CR8 CR9\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] vs. DD: 8 [\u003cspan additionalcitationids=\"CR7 CR8 CR9\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]), and 3 minutes (EMLA: 6 [\u003cspan additionalcitationids=\"CR5 CR6 CR7\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] vs. DD: 6 [\u003cspan additionalcitationids=\"CR5 CR6 CR7\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]), with significantly smaller increases from baseline in the EMLA phase (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001 across all time points). The upper bounds of the 95% confidence intervals exceeded the 1-point non-inferiority margin; DD was not non-inferior. No adverse events occurred.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eIn this crossover study, EMLA cream provided superior procedural analgesia compared with digital distraction at all post-cannulation time points. While DD offered partial pain reduction, it did not achieve non-inferiority and may be best used as an adjunct in settings where topical anesthetics are unavailable or impractical. Combined application of pharmacological and digital distraction strategies may offer optimal pediatric comfort during IV procedures.\u003c/p\u003e","manuscriptTitle":"Easing the Sting: A Paired Crossover Study Comparing Pain Relief with EMLA Cream vs Digital Distraction During Pediatric IV Cannulation","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-22 17:17:49","doi":"10.21203/rs.3.rs-8193507/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-01-06T00:24:51+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-05T20:44:24+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"299227300816494747973345479694985676136","date":"2025-12-24T18:34:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"110074589594972392426235703326935601815","date":"2025-12-19T01:56:28+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-12-18T22:21:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"145009153535750751682350607872763319082","date":"2025-12-18T17:16:23+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-12-18T11:30:57+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-11-27T06:36:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-11-26T11:04:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-11-26T11:04:14+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pediatrics","date":"2025-11-24T12:34:59+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"62ff65bf-90e6-47dc-b9db-9c2b735154f9","owner":[],"postedDate":"December 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T17:17:49+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-22 17:17:49","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8193507","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8193507","identity":"rs-8193507","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.