Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study

Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study | 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 Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study SYKORA Roman, KUKACKOVA Nikola, SOPKO Ondrej, PERAN David, SMETANA Jiri, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6643859/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 09 Sep, 2025 Read the published version in European Journal of Trauma and Emergency Surgery → Version 1 posted 11 You are reading this latest preprint version Abstract Background and importance In the Czech Republic, paramedics are required to consult a physician before administering intravenous opioids, which may delay effective prehospital pain management. As paramedic competencies expand in Europe, it is important to evaluate the safety and efficacy of independent opioid administration in real-world emergency medical settings. Objectives To assess the safety and effectiveness of intravenous sufentanil administered independently by trained paramedics compared to administration following remote physician consultation in adult trauma patients. Design Prospective, single-center, observational cohort study. Settings and participants Conducted at the Emergency Medical Services of the Karlovy Vary Region between January 1 and December 31, 2024. The study included 462 adult trauma patients who were hemodynamically stable and conscious. Patients were divided into two groups: the Consultation group (physician consultation required) and the Competency group (paramedics administering independently). Intervention or exposure Intravenous administration of sufentanil, with or without physician phone consultation. Outcome measures and analysis Primary outcomes included reduction in pain (measured using the Numeric Rating Scale, NRS) and incidence of adverse events (e.g., respiratory depression, oxygen desaturation, hypotension, and antiemetic use). Statistical significance was set at p<0.05. Main results Both groups achieved similar pain reduction. The Competency group received a higher mean dose of sufentanil (9.7 ± 3.0 µg vs 8.9 ± 2.8 µg; p=0.006) and more frequently used non-opioid adjuvant analgesics (54% vs 41%). Documentation of pain scores was significantly better in the Competency group (87% vs 43%; p<0.01). Adverse events were rare, non-serious, and comparable between groups. Antiemetics were more frequently administered in the Competency group (11% vs 6%; p=0.037). A minor, clinically insignificant reduction in diastolic blood pressure was observed in the Competency group. Conclusion Independent administration of intravenous sufentanil by trained paramedics was as safe and effective as physician-supervised administration, with better documentation and more frequent multimodal analgesia. These findings support expanding paramedic competencies in opioid analgesia within the Czech prehospital emergency system. paramedic competencies pre-hospital analgesia opioid sufentanil low-severity trauma Figures Figure 1 Introduction In the Czech Republic, current legislation does not permit paramedics operating without a physician to administer intravenous opioids in prehospital emergency care (PEC). This limitation presents a significant challenge in the management of acute traumatic pain, as paramedics must consult a remote physician by phone before initiating opioid analgesia. In contrast, several European countries allow paramedics to administer opioid analgesics independently, with authorization typically based on specific training and protocol-driven approaches. [ 1 , 2 ] Previous pilot studies in the Czech Republic, as well as research conducted by German team [ 3 ], have explored this issue [ 4 ]. Notably, recent changes in German legislation have enabled paramedics to administer opioid analgesia in defined situations without direct physician oversight. [ 5 ] Given the structural and procedural similarities between the Czech and German PEC systems, this remains a timely and relevant topic in the Czech context. In the Czech Republic, as in many other European countries, sufentanil is among the most commonly used opioids for managing traumatic pain in the PEC setting. [ 6 , 7 ] This study seeks to contribute to the growing body of evidence informing the potential extension of paramedic competencies within the Czech system in European context. [8] Specifically, it investigates the clinical effectiveness and safety of autonomous intravenous administration of sufentanil by appropriately trained paramedics in adult patients presenting with moderate acute traumatic pain, following a standardized protocol. Methods Since 2020, Emergency Medical Services (EMS) of the Karlovy Vary Region in the Czech Republic has been piloting the use of opioid treatment for pain management in trauma cases. [ 4 ] This competency is optional for paramedics and is granted following a structured training process.[ 4 ] The process includes e-learning modules, in-house lectures, and simulation-based sessions, all of which involve assessment of both knowledge and practical skills. Re-certification was required for paramedics every twenty-four months. Participation data such as age, gender, years of experience, and level of medical education (university degree or higher professional qualification) were tracked among paramedics. Study design This study was conducted in accordance with the STROBE guidelines to ensure transparent and complete reporting.[ 9 ] This study was designed as a single-center, prospective, observational cohort trial with two parallel groups. The study protocol and its implementation were approved by the Ethics Committee of the EMS of the Karlovy Vary Region, registered with the State Institute for Drug Control of the Czech Republic, on August 11, 2024 (Reference No. ZZSKVK/EK/01/2024). In accordance with Czech legislation (Health Services Act No. 2011, 372 (CZ), informed consent was not required from patients presenting with acute traumatic pain in PEC.[ 10 ] Instead, participation was based on the principle of tacit consent, following the provision of standard information about the proposed procedures. The trial was registered at ClinicalTrials.gov (Identifier: NCT06514469) on July 16, 2024. Study location The study was conducted at the EMS of the Karlovy Vary Region, Czech Republic, over a 12-month period from January 1, 2024, to December 31, 2024. Data source and eligibility criteria All data were retrieved from the electronic patient documentation system ePaRe (part of MZD, European Medical Distribution Ltd., Bratislava, Slovak Republic). Patients were eligible for inclusion if they met the following criteria: a) sufentanil was administered by paramedics on scene without the physical presence of a physician, b) the patient was at least 18 years old, c) the patient was fully conscious (defined as Alert with a Glasgow Coma Scale score of 15), and d) the patient was hemodynamically stable (systolic blood pressure > 100 mmHg and no bradycardia, i.e., heart rate ≥ 60 bpm). Consequently, two study groups were identified based on the method of sufentanil administration: Consultation group – patients who received sufentanil administered by paramedics after telephone consultation with an EMS physician, and Competency group – patients who received sufentanil administered independently by trained and authorized paramedics. In the Competency group, paramedics were allowed to administer intravenous sufentanil in titrated doses up to a maximum of 20 micrograms. Administration was considered appropriate when the patient's reported pain score on the Numeric Rating Scale (NRS) was greater than 4 points. Baseline characteristics were collected from electronic patient records, including age, sex, NACA score (National Advisory Committee for Aeronautics), type of injury (upper or lower limb, torso, head or burns), sufentanil dose and whether it was administered fractionally, and the proportion of cases in which additional non-opioid analgesia (paracetamol) was used. Outcome Measures Ambulance response times and on scene times, the sufentanil dosing and additional analgesia were extracted. Efficacy was evaluated by the frequency of complete Numeric Rating Scale (NRS) pain assessments, recorded both prior to sufentanil administration and at patient handover. The safety outcomes included the incidence of respiratory arrest (defined as the need for bag-valve-mask ventilation), bradypnea (respiratory rate < 10 breaths per minute), and the requirement for oxygen therapy (SpO₂ <92%). Recorded adverse effects were assessed, including the incidence of nausea and vomiting and the need for intravenous antiemetic treatment. Furthermore, changes in physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and respiratory rate, were recorded from initial assessment through to patient handover. Data Presentation and Statistical Analysis Continuous variables are presented as mean ± standard deviation, while categorical variables are expressed as counts (n) and percentages. The Kolmogorov–Smirnov test was used to assess the normality of continuous data. Depending on the data type and distribution, appropriate statistical tests were applied, including the t-test, Chi-square test, and Fisher’s exact test. A p-value of < 0.05 was considered statistically significant. All analyses were conducted using STATISTICA 7.0 (StatSoft, Inc., Tulsa, Oklahoma, USA). The sample size was not calculated in advance; however, the protocol initially defined a target of 100 cases per group and a data collection period of six months. Subsequently, following agreement within the research team, the study period was extended to one year. Results In the observed year (2024), 112 paramedics worked in the ambulance crew, with half having the competency to administer sufentanil independently (n = 56). Details and a comparison of paramedics with and without competency are shown in Table S1 of the supplementary material. The selection of study groups is outlined in the study flow diagram (Fig. 1 ). Of the total 45,344 EMS interventions in 2024, 233 cases of sufentanil administration occurred in the 'Consultation' group (where a physician was consulted by phone), and 229 cases in the 'Competence' group (administered by paramedics with competency). The baseline characteristics of both study groups are summarized in Table 1 . Table 1. Baseline characteristics CONSULTATION (n = 233) COMPETENCE (n = 229) Age (years) 62.9 (21.4) 64.1 (20.0) Sex (women) 136 (58%) 143 (62%) Ambulance response time (min) 10.5 (5.3) 10.6 (5.1) NACA 2.9 (0.5) 2.8 (0.4) Trauma of lower extremity 158 (68%) 145 (63%) Trauma of upper extremity 45 (19%) 53 (23%) Trauma of torso 21 (9%) 26 (11%) Trauma of head 5 (2%) 5 (2%) Burns 4 (2%) -- Data are presented as mean (standard deviation) or as number (percentage). Abbreviations: MDC – Medical Dispatching Center; NACA – National Advisory Committee for Aeronautics score. Despite the mandatory telephone consultation, paramedics in the Consultation group spent a comparable amount of time on scene as those authorized to administer sufentanil independently ( Competency ). However, the dose of intravenously administered sufentanil in the Consultation group was significantly lower than in the independent competence group (8.9 ± 2.8 µg vs 9.7 ± 3.0 µg, p = 0.006). Non-opioid adjuvant analgesia was less frequently administered in the Consultation group (41% vs 54%). Although the reduction in NRS scores was calculated to be similar in both groups, complete NRS documentation was significantly less frequent in the Consultation group (43% vs 87%, p < 0.01) (Table 2 ). Table 2 On-scene time, characteristics of analgesia, and pain reduction CONSULTATION (n = 233) COMPETENCE (n = 229) p-value Ambulance on scene time (min) 26.0 (9.8) 25.1 (9.5) NS Dose of sufentanil (µg) 8.9 (2.8) 9.7 (3.0) # 0.006 Fractional administration (documented) 65 (28%) 74 (32%) NS Additional i.v. paracetamol use 79 (34%) 124 (54%) # < .001 Other additional analgesics 17 (7%) 0 # < .05 NRS, initial (points 0–10) 7.6 (1.7) 7.4 (1.8) NS NRS reduction (points) − 3.8 (1.9) − 4.0 (1.8) NS Complete NRS reporting 100 (43%) 199 (87%) # < .001 Data are presented as mean (standard deviation) or as number (percentage). Abbreviations: NRS – Numeric Rating Scale for subjective pain assessment; i.v. – intravenous; NS – not significant; # Statistically significant with presented p-value. Adverse events such as respiratory depression, need for oxygen therapy, hypotension, nausea, or vomiting were infrequent and occurred at similar rates in both groups. However, intravenous antiemetics were administered more often in the Competence group (11% vs 6%; p = 0.037) (Table 3 ). A reduction in diastolic blood pressure prior to handover was observed in the Competence group (-2.5 ± 9.6 vs + 1.8 ± 8.2 mmHg), while other vital signs including, systolic blood pressure, heart rate, respiratory rate, SpO₂, and GCS, remained unchanged (Table 4 and Supplementary material Table S3). Table 3 Adverse events and their treatment following intravenous sufentanil use in trauma care CONSULTATION (n = 233) COMPETENCE (n = 229) p-value Respiratory arrest - - - Bradypnea, hypoventilation - 1 (< 1%) NS Hyposaturation 4* (2%) 5**(2%) NS Oxygen therapy needed 19 (8%) 17 (7%) NS Hypotension - 1 (< 1%) NS Nausea 5 (2%) 11 (5%) NS Vomiting - 3 (1%) NS Antiemetics administration 13 (6%) 25 (11%) # .037 Data are presented as number and percentage; * Number of all the 7 reported cases of desaturation, 3 occurred prior to sufentanil administration and ** number of the 8 reported cases of desaturation, 3 occurred prior to sufentanil administration due to a chronic condition (chronic obstructive pulmonary disease). Antiemetics administered included ondansetron or thiethylperazine. NS – not significant; # Statistically significant with presented p-value. Table 4 Impact of intravenous sufentanil administration on changes in physiological parameters in trauma patients Difference from initial physiologic values throughout to handover. CONSULTATION (n = 233) COMPETENCE (n = 229) p-value Systolic BP (mmHg) -5.3 (15.6) -5,4 (12.8) NS Diastolic BP (mmHg) + 1.8 (8.2) -2.5 (9.6) # < 0.001 HR difference (bpm) 1 -2.4 (10.7) -2.1 (9.5) NS SpO2 (%) + 0.3 (3.5) -0.1 (2.2) NS RR (breaths per minute) -0.7 (2.1) -0.6 (1.7) NS Glasgow Coma Scale 0 (0.3) 0 (0.1) NS Data are presented as mean (standard deviation). Abbreviations: BP – blood pressure; HR – heart rate; SpO₂ – peripheral oxygen saturation; RR – respiratory rate. Differences reflect changes between initial values and those recorded at handover in the emergency department. Negative sign means decrease from on-scene initial values. NS – not significant; # Statistically significant with presented p-value. Discussion This prospective cohort study evaluated the effectiveness and safety of protocolized intravenous sufentanil administration by paramedics in the Czech Republic, comparing those authorized to administer independently after voluntary training with those requiring remote telephone consultation with an EMS physician. Our findings demonstrate that trained paramedics can safely and effectively manage moderate traumatic pain without physician supervision, supporting the potential expansion of paramedic competencies within the Czech PEC system. Scene times did not differ significantly between groups, suggesting that the procedural delay introduced by physician phone consultation is minimal. However, paramedics in the Competency group administered a slightly but significantly higher dose of sufentanil compared to the Consultation group. This modest difference may reflect greater confidence in titrating opioids among independently authorized paramedics, aligning with international findings that autonomy improves pain management outcomes.[ 3 , 11 , 12 ] Moreover, the Competency group more frequently used adjuvant non-opioid analgesia, despite identical protocol permissions across groups. This suggests that voluntary, protocol-based training not only enhances opioid titration but also promotes proactive multimodal pain strategies, consistent with best practice in prehospital care. [ 13 ] Pain relief, measured via changes in the NRS score, was similar in both groups. However, complete documentation of pre- and post-administration pain scores was significantly more frequent in the Competency group, indicating better adherence to outcome monitoring protocols. This reflects improved clinical accountability and record quality when paramedics are specifically trained for autonomous opioid administration. Regarding safety, adverse events such as respiratory depression, oxygen desaturation, hypotension, and nausea were rare and occurred at comparable rates between groups. Notably, the use of intravenous antiemetics was higher in the Competency group, despite similar rates of nausea and vomiting. This may reflect a more anticipatory and patient-centered approach by trained paramedics. Only diastolic blood pressure showed a small but statistically significant decrease in the Competency group before patient handover, remaining within clinically acceptable ranges. Other vital signs, including heart rate, respiratory rate, SpO₂, and GCS, remained stable, confirming the hemodynamic safety of protocolized sufentanil use. Our findings are consistent with previous studies from Germany and other European systems, which have shown that opioid analgesia administered by trained paramedics under strict protocols is both feasible and safe. [ 3 , 11 , 13 , 14 ] Additionally, Le Cornec et al. compared ketamine to morphine for out-of-hospital analgesia and found similar efficacy between the two agents, but differing side effect profiles.[ 15 ] Ketamine was associated with a higher incidence of dissociation and agitation, while morphine had more nausea.[ 15 ] Nevertheless, low-dose sufentanil administration in less severe trauma in our study produced very low rates of adverse effects, particularly those that could impair communication and cooperation in prehospital settings. [ 4 , 16 ] Overall, this study suggests that sufentanil administration by paramedics, when supported by voluntary structured training and protocol-based authorization, is safe, effective, and feasible in the Czech PEC system. Furthermore, it underscores the broader principle that enhancing paramedic autonomy, backed by rigorous education, can improve the quality of analgesia without compromising patient safety. Limitations However, certain limitations must be acknowledged. As with all observational studies, the possibility of unmeasured confounding cannot be fully excluded. The study was also restricted to a single region, which may limit generalizability. Additionally, incomplete pain score documentation in the Consultation group could introduce measurement bias. Future multicenter trials and registry-based surveillance are recommended to validate these findings across different EMS systems and to explore the role of alternative agents such as ketamine in paramedic-administered analgesia. Conclusion This study supports the safe and effective administration of intravenous sufentanil by trained paramedics operating under a protocolized competency system. Compared with the traditional model requiring remote physician consultation, autonomous administration was associated with comparable safety, greater use of multimodal analgesia, and improved adherence to outcome documentation. These findings offer practical and evidence-based guidance for the potential expansion of paramedic scope of practice in the Czech Republic. Declarations Supplemental Digital Content Detailed paramedics, baseline and efficacy, adverse event and physiologic values are mentioned in tables of supplemental digital content. Author Contributions RS : Conceptualization; Methodology; Investigation, Data curation; Formal analysis; Writing - original draft; Project administration; NK : Data curation; Methodology; Writing – review and editing; OS : Investigation; Writing – review and editing; DP : Methodology and protocol; Writing – review and editing; JS : Supervision; Writing -review and editing; MR : Methodology; Writing – review and editing; MK: Methodology; Supervision; Writing – review and editing. Each author has been involved in drafting and critically revising the manuscript and has approved the final version for submission. Funding This research received no external funding. The study was conducted entirely within the Emergency Medical Services of the Karlovy Vary Region, Czech Republic. Competing Interests The authors declare that they have no competing interests related to this study. Ethical Approval and Consent to Participate The study was conducted in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments. Ethical approval was obtained from the relevant ethics committee. Informed consent was not required for this type of observational study. Consent for Publication Not applicable. Availability of Data and Materials The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request. Use of AI and AI-Assisted Technologies in the Writing Process During the preparation of this manuscript, the authors utilized ChatGPT (OpenAI) to assist in correcting English grammar and enhancing language clarity. All content was reviewed and edited by the authors to ensure accuracy and integrity. The authors take full responsibility for the content of the manuscript. References Colding-Jørgensen JT, Brandstrup GMG, Nielsen VML, Gradman J, Thybo LAB, Hansen PM, Wittrock D, Blomberg SNF, Christensen HC, Mikkelsen S. The use of strong analgesics for prehospital pain management in children in the region of Southern Denmark: a register-based study. Scand J Trauma Resusc Emerg Med. 2025;33(1):23. Kiavialaitis GE, Müller S, Braun J, Rössler J, Spahn DR, Stein P, Kaserer A. Clinical practice of pre-hospital analgesia: An observational study of 20,978 missions in Switzerland. Am J Emerg Med. 2020;38(11):2318–23. Scharonow M, Alberding T, Oltmanns W, Weilbach C. Project for the introduction of prehospital analgesia with fentanyl and morphine administered by specially trained paramedics in a rural service area in Germany. J Pain Res. 2017;10:2595–9. Renza M, Sykora R, Peran D, Hricova K, Brizgalova N, Bakurova P, Kukacka M. Pilot implementation of the competence of Czech paramedics to administer sufentanil for the treatment of pain in acute trauma without consulting a physician: observational study. BMC Emerg Med. 2022;22(1):63. Vilcane S, Scharonow O, Weilbach C, Scharonow M. Application of analgesics in emergency services in Germany: a survey of the medical directors. BMC Emerg Med. 2023;23(1):104. Hachimi-Idrissi S, Dobias V, Hautz WE, Leach R, Sauter TC, Sforzi I, et al. Approaching acute pain in emergency settings; European Society for Emergency Medicine (EUSEM) guidelines-part 2: management and recommendations. Intern Emerg Med. 2020;15(7):1141–55. Vilcane S, Scharonow O, Weilbach C, Scharonow M. Application of analgesics in emergency services in Germany: a survey of the medical directors. BMC Emerg Med. 2023;23(1):104. Erratum in: BMC Emerg Med. 2025;25(1):71. European Society for Emergency Medicine. Guidelines for the management of acute pain in emergency situations. March 2020. Accessed April 28, 2025. https://www.eusem.org/images/EUSEM_EPI_GUIDELINES_MARCH_2020.pdf von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344–9. Ministry of Health of the Czech Republic. Decree No. 55/2011 Coll. on the activities of medical staff and other professionals. Collection of Laws of the Czech Republic; 2011. Friesgaard KD, Vist GE, Hyldmo PK, Raatiniemi L, Kurola J, Larsen R, et al. Opioids for treatment of pre-hospital acute pain: a systematic review. Pain Ther. 2022;11(1):17–36. Dalton MK, Semco RS, Ordoobadi AJ, Goralnick E, Chovanes J, Salim A, et al. Opioid administration in the prehospital setting for patients sustaining traumatic injuries: an evaluation of national emergency medical services data. Injury. 2022;53(9):2923–9. Deslandes M, Deicke M, Grannemann JJ, Hinkelbein J, Hoyer A, Kalmbach M, et al. Effectiveness and safety of prehospital analgesia with nalbuphine and paracetamol versus morphine by paramedics: an observational study. Scand J Trauma Resusc Emerg Med. 2024;32(1):41. Friesgaard KD, Kirkegaard H, Rasmussen CH, Giebner M, Christensen EF, Nikolajsen L. Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols. Scand J Trauma Resusc Emerg Med. 2019;27(1):11. Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, et al. Ketamine compared with morphine for out-of-hospital analgesia for patients with traumatic pain: a randomized clinical trial. JAMA Netw Open. 2024;7(1):e2352844. Sandberg M, Hyldmo PK, Kongstad P, Dahl Friesgaard K, Raatiniemi L, Larsen R, Magnusson V, et al. Ketamine for the treatment of prehospital acute pain: a systematic review of benefit and harm. BMJ Open. 2020;10(11):e038134. Additional Declarations No competing interests reported. Supplementary Files 5Sufenta2SuplementalDigitalContentV4.docx Cite Share Download PDF Status: Published Journal Publication published 09 Sep, 2025 Read the published version in European Journal of Trauma and Emergency Surgery → Version 1 posted Editorial decision: Revision requested 10 Jun, 2025 Reviews received at journal 05 Jun, 2025 Reviews received at journal 31 May, 2025 Reviews received at journal 21 May, 2025 Reviewers agreed at journal 19 May, 2025 Reviewers agreed at journal 19 May, 2025 Reviewers agreed at journal 18 May, 2025 Reviewers invited by journal 18 May, 2025 Editor assigned by journal 18 May, 2025 Submission checks completed at journal 13 May, 2025 First submitted to journal 12 May, 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. 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07:23:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6643859/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6643859/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00068-025-02953-0","type":"published","date":"2025-09-09T15:57:01+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82708178,"identity":"48ff3573-d72a-4364-ac93-aefefe4e229f","added_by":"auto","created_at":"2025-05-14 10:59:15","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":20614,"visible":true,"origin":"","legend":"\u003cp\u003eIdentification of patient groups with acute trauma receiving sufentanil administered exclusively by paramedics without on-scene physician 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10:59:15","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":28096,"visible":true,"origin":"","legend":"","description":"","filename":"5Sufenta2SuplementalDigitalContentV4.docx","url":"https://assets-eu.researchsquare.com/files/rs-6643859/v1/9a5235634e423f9e75a95c14.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIn the Czech Republic, current legislation does not permit paramedics operating without a physician to administer intravenous opioids in prehospital emergency care (PEC). This limitation presents a significant challenge in the management of acute traumatic pain, as paramedics must consult a remote physician by phone before initiating opioid analgesia. In contrast, several European countries allow paramedics to administer opioid analgesics independently, with authorization typically based on specific training and protocol-driven approaches. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/p\u003e \u003cp\u003ePrevious pilot studies in the Czech Republic, as well as research conducted by German team [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], have explored this issue [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Notably, recent changes in German legislation have enabled paramedics to administer opioid analgesia in defined situations without direct physician oversight. [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Given the structural and procedural similarities between the Czech and German PEC systems, this remains a timely and relevant topic in the Czech context.\u003c/p\u003e \u003cp\u003eIn the Czech Republic, as in many other European countries, sufentanil is among the most commonly used opioids for managing traumatic pain in the PEC setting. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] This study seeks to contribute to the growing body of evidence informing the potential extension of paramedic competencies within the Czech system in European context. [8] Specifically, it investigates the clinical effectiveness and safety of autonomous intravenous administration of sufentanil by appropriately trained paramedics in adult patients presenting with moderate acute traumatic pain, following a standardized protocol.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eSince 2020, Emergency Medical Services (EMS) of the Karlovy Vary Region in the Czech Republic has been piloting the use of opioid treatment for pain management in trauma cases. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] This competency is optional for paramedics and is granted following a structured training process.[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] The process includes e-learning modules, in-house lectures, and simulation-based sessions, all of which involve assessment of both knowledge and practical skills. Re-certification was required for paramedics every twenty-four months. Participation data such as age, gender, years of experience, and level of medical education (university degree or higher professional qualification) were tracked among paramedics.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003e This study was conducted in accordance with the STROBE guidelines to ensure transparent and complete reporting.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e9\u003c/span\u003e] This study was designed as a single-center, prospective, observational cohort trial with two parallel groups. The study protocol and its implementation were approved by the Ethics Committee of the EMS of the Karlovy Vary Region, registered with the State Institute for Drug Control of the Czech Republic, on August 11, 2024 (Reference No. ZZSKVK/EK/01/2024). In accordance with Czech legislation (Health Services Act No. 2011, 372 (CZ), informed consent was not required from patients presenting with acute traumatic pain in PEC.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e10\u003c/span\u003e] Instead, participation was based on the principle of tacit consent, following the provision of standard information about the proposed procedures. The trial was registered at ClinicalTrials.gov (Identifier: NCT06514469) on July 16, 2024.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy location\u003c/h3\u003e\n\u003cp\u003eThe study was conducted at the EMS of the Karlovy Vary Region, Czech Republic, over a 12-month period from January 1, 2024, to December 31, 2024.\u003c/p\u003e\n\u003ch3\u003eData source and eligibility criteria\u003c/h3\u003e\n\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eAll data were retrieved from the electronic patient documentation system \u003cem\u003eePaRe\u003c/em\u003e (part of MZD, European Medical Distribution Ltd., Bratislava, Slovak Republic). Patients were eligible for inclusion if they met the following criteria: a) sufentanil was administered by paramedics on scene without the physical presence of a physician, b) the patient was at least 18 years old, c) the patient was fully conscious (defined as Alert with a Glasgow Coma Scale score of 15), and d) the patient was hemodynamically stable (systolic blood pressure\u0026thinsp;\u0026gt;\u0026thinsp;100 mmHg and no bradycardia, i.e., heart rate\u0026thinsp;\u0026ge;\u0026thinsp;60 bpm). Consequently, two study groups were identified based on the method of sufentanil administration: \u003cem\u003eConsultation\u003c/em\u003e group \u0026ndash; patients who received sufentanil administered by paramedics after telephone consultation with an EMS physician, and\u003c/p\u003e \u003cp\u003e \u003cem\u003eCompetency\u003c/em\u003e group \u0026ndash; patients who received sufentanil administered independently by trained and authorized paramedics.\u003c/p\u003e \u003cp\u003eIn the \u003cem\u003eCompetency\u003c/em\u003e group, paramedics were allowed to administer intravenous sufentanil in titrated doses up to a maximum of 20 micrograms. Administration was considered appropriate when the patient's reported pain score on the Numeric Rating Scale (NRS) was greater than 4 points.\u003c/p\u003e \u003cp\u003eBaseline characteristics were collected from electronic patient records, including age, sex, NACA score (National Advisory Committee for Aeronautics), type of injury (upper or lower limb, torso, head or burns), sufentanil dose and whether it was administered fractionally, and the proportion of cases in which additional non-opioid analgesia (paracetamol) was used.\u003c/p\u003e\n\u003ch3\u003eOutcome Measures\u003c/h3\u003e\n\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eAmbulance response times and on scene times, the sufentanil dosing and additional\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003eanalgesia were extracted. Efficacy was evaluated by the frequency of complete Numeric Rating Scale (NRS) pain assessments, recorded both prior to sufentanil administration and at patient handover. The safety outcomes included the incidence of respiratory arrest (defined as the need for bag-valve-mask ventilation), bradypnea (respiratory rate\u0026thinsp;\u0026lt;\u0026thinsp;10 breaths per minute), and the requirement for oxygen therapy (SpO₂ \u0026lt;92%). Recorded adverse effects were assessed, including the incidence of nausea and vomiting and the need for intravenous antiemetic treatment. Furthermore, changes in physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and respiratory rate, were recorded from initial assessment through to patient handover.\u003c/p\u003e\n\u003ch3\u003eData Presentation and Statistical Analysis\u003c/h3\u003e\n\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eContinuous variables are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation, while categorical\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003evariables are expressed as counts (n) and percentages. The Kolmogorov\u0026ndash;Smirnov test was used to assess the normality of continuous data. Depending on the data type and distribution, appropriate statistical tests were applied, including the t-test, Chi-square test, and Fisher\u0026rsquo;s exact test. A p-value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant. All analyses were conducted using STATISTICA 7.0 (StatSoft, Inc., Tulsa, Oklahoma, USA). The sample size was not calculated in advance; however, the protocol initially defined a target of 100 cases per group and a data collection period of six months. Subsequently, following agreement within the research team, the study period was extended to one year.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eIn the observed year (2024), 112 paramedics worked in the ambulance crew, with half having the competency to administer sufentanil independently (n\u0026thinsp;=\u0026thinsp;56). Details and a comparison of paramedics with and without competency are shown in Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e of the supplementary material. The selection of study groups is outlined in the study flow diagram (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Of the total 45,344 EMS interventions in 2024, 233 cases of sufentanil administration occurred in the \u003cem\u003e'Consultation'\u003c/em\u003e group (where a physician was consulted by phone), and 229 cases in the \u003cem\u003e'Competence'\u003c/em\u003e group (administered by paramedics with competency). The baseline characteristics of both study groups are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e\u003cstrong\u003eTable 1. Baseline characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003eCONSULTATION\u003c/p\u003e\n \u003cp\u003e(n = 233)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003eCOMPETENCE\u003c/p\u003e\n \u003cp\u003e(n = 229)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eAge (years)\u003csup\u003e\u0026nbsp;\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e62.9 (21.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e64.1 (20.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eSex (women)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e136 (58%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e143 (62%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eAmbulance response time (min)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e10.5 (5.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e10.6 (5.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eNACA\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e2.9 (0.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e2.8 (0.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eTrauma of lower extremity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e158 (68%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e145 (63%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eTrauma of upper extremity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e45 (19%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e53 (23%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eTrauma of torso\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e21 (9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e26 (11%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eTrauma of head\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e5 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e5 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 255px;\"\u003e\n \u003cp\u003eBurns\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e4 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e--\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eData are presented as mean (standard deviation) or as number (percentage). Abbreviations: MDC \u0026ndash; Medical Dispatching Center; NACA \u0026ndash; National Advisory Committee for Aeronautics score.\u003c/em\u003e\u003c/p\u003e\u003cp\u003eDespite the mandatory telephone consultation, paramedics in the \u003cem\u003eConsultation\u003c/em\u003e group spent a comparable amount of time on scene as those authorized to administer sufentanil independently (\u003cem\u003eCompetency\u003c/em\u003e). However, the dose of intravenously administered sufentanil in the \u003cem\u003eConsultation\u003c/em\u003e group was significantly lower than in the independent competence group\u003c/p\u003e \u003cp\u003e(8.9\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8 \u0026micro;g vs 9.7\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0 \u0026micro;g, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.006). Non-opioid adjuvant analgesia was less frequently administered in the \u003cem\u003eConsultation\u003c/em\u003e group (41% vs 54%). Although the reduction in NRS scores was calculated to be similar in both groups, complete NRS documentation was significantly less frequent in the \u003cem\u003eConsultation\u003c/em\u003e group (43% vs 87%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOn-scene time, characteristics of analgesia, and pain reduction\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCONSULTATION\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;233)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCOMPETENCE\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;229)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmbulance on scene time (min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.0 (9.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.1 (9.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDose of sufentanil (\u0026micro;g)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.9 (2.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.7 (3.0) \u003cem\u003e#\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.006\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFractional administration (documented)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65 (28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74 (32%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdditional i.v. paracetamol use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79 (34%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e124 (54%) \u003cem\u003e#\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther additional analgesics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 \u003cem\u003e#\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.05\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNRS, initial (points 0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.6 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.4 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNRS reduction (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026minus;\u0026thinsp;3.8 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026minus;\u0026thinsp;4.0 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComplete NRS reporting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100 (43%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e199 (87%) \u003cem\u003e#\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003cem\u003eData are presented as mean (standard deviation) or as number (percentage). Abbreviations: NRS \u0026ndash; Numeric Rating Scale for subjective pain assessment; i.v. \u0026ndash; intravenous; NS \u0026ndash; not significant; # Statistically significant with presented p-value.\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAdverse events such as respiratory depression, need for oxygen therapy, hypotension, nausea, or vomiting were infrequent and occurred at similar rates in both groups. However, intravenous antiemetics were administered more often in the \u003cem\u003eCompetence\u003c/em\u003e group (11% vs 6%; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.037) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). A reduction in diastolic blood pressure prior to handover was observed in the \u003cem\u003eCompetence\u003c/em\u003e group (-2.5\u0026thinsp;\u0026plusmn;\u0026thinsp;9.6 vs\u0026thinsp;+\u0026thinsp;1.8\u0026thinsp;\u0026plusmn;\u0026thinsp;8.2 mmHg), while other vital signs including, systolic blood pressure, heart rate, respiratory rate, SpO₂, and GCS, remained unchanged (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and Supplementary material Table S3).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse events and their treatment following intravenous sufentanil use in trauma care\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCONSULTATION\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;233)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCOMPETENCE\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;229)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory arrest\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBradypnea, hypoventilation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u0026lt;\u0026thinsp;1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyposaturation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4* (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5**(2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOxygen therapy needed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17 (7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypotension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u0026lt;\u0026thinsp;1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNausea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVomiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiemetics administration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (11%) \u003cem\u003e#\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e.037\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003cem\u003eData are presented as number and percentage; * Number of all the 7 reported cases of desaturation, 3 occurred prior to sufentanil administration and ** number of the 8 reported cases of desaturation, 3 occurred prior to sufentanil administration due to a chronic condition (chronic obstructive pulmonary disease). Antiemetics administered included ondansetron or thiethylperazine. NS \u0026ndash; not significant; # Statistically significant with presented p-value.\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eImpact of intravenous sufentanil administration on changes in physiological parameters in trauma patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDifference from initial physiologic values throughout to handover.\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCONSULTATION\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;233)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCOMPETENCE\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;229)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSystolic BP (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-5.3 (15.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-5,4 (12.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiastolic BP (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e+\u0026thinsp;1.8 (8.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-2.5 (9.6) #\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHR difference (bpm)\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-2.4 (10.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-2.1 (9.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpO2 (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e+\u0026thinsp;0.3 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.1 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRR (breaths per minute)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.7 (2.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e-0.6 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGlasgow Coma Scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0 (0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0 (0.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003cem\u003eData are presented as mean (standard deviation). Abbreviations: BP \u0026ndash; blood pressure; HR \u0026ndash; heart rate; SpO₂ \u0026ndash; peripheral oxygen saturation; RR \u0026ndash; respiratory rate. Differences reflect changes between initial values and those recorded at handover in the emergency department. Negative sign means decrease from on-scene initial values. NS \u0026ndash; not significant; # Statistically significant with presented p-value.\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis prospective cohort study evaluated the effectiveness and safety of protocolized intravenous sufentanil administration by paramedics in the Czech Republic, comparing those authorized to administer independently after voluntary training with those requiring remote telephone consultation with an EMS physician. Our findings demonstrate that trained paramedics can safely and effectively manage moderate traumatic pain without physician supervision, supporting the potential expansion of paramedic competencies within the Czech PEC system.\u003c/p\u003e \u003cp\u003eScene times did not differ significantly between groups, suggesting that the procedural delay introduced by physician phone consultation is minimal. However, paramedics in the Competency group administered a slightly but significantly higher dose of sufentanil compared to the Consultation group. This modest difference may reflect greater confidence in titrating opioids among independently authorized paramedics, aligning with international findings that autonomy improves pain management outcomes.[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eMoreover, the Competency group more frequently used adjuvant non-opioid analgesia, despite identical protocol permissions across groups. This suggests that voluntary, protocol-based training not only enhances opioid titration but also promotes proactive multimodal pain strategies, consistent with best practice in prehospital care. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003ePain relief, measured via changes in the NRS score, was similar in both groups. However, complete documentation of pre- and post-administration pain scores was significantly more frequent in the Competency group, indicating better adherence to outcome monitoring protocols. This reflects improved clinical accountability and record quality when paramedics are specifically trained for autonomous opioid administration.\u003c/p\u003e \u003cp\u003eRegarding safety, adverse events such as respiratory depression, oxygen desaturation, hypotension, and nausea were rare and occurred at comparable rates between groups. Notably, the use of intravenous antiemetics was higher in the Competency group, despite similar rates of nausea and vomiting. This may reflect a more anticipatory and patient-centered approach by trained paramedics.\u003c/p\u003e \u003cp\u003eOnly diastolic blood pressure showed a small but statistically significant decrease in the Competency group before patient handover, remaining within clinically acceptable ranges. Other vital signs, including heart rate, respiratory rate, SpO₂, and GCS, remained stable, confirming the hemodynamic safety of protocolized sufentanil use.\u003c/p\u003e \u003cp\u003eOur findings are consistent with previous studies from Germany and other European systems, which have shown that opioid analgesia administered by trained paramedics under strict protocols is both feasible and safe. [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e14\u003c/span\u003e] Additionally, Le Cornec et al. compared ketamine to morphine for out-of-hospital analgesia and found similar efficacy between the two agents, but differing side effect profiles.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e15\u003c/span\u003e] Ketamine was associated with a higher incidence of dissociation and agitation, while morphine had more nausea.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e15\u003c/span\u003e] Nevertheless, low-dose sufentanil administration in less severe trauma in our study produced very low rates of adverse effects, particularly those that could impair communication and cooperation in prehospital settings. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eOverall, this study suggests that sufentanil administration by paramedics, when supported by voluntary structured training and protocol-based authorization, is safe, effective, and feasible in the Czech PEC system. Furthermore, it underscores the broader principle that enhancing paramedic autonomy, backed by rigorous education, can improve the quality of analgesia without compromising patient safety.\u003c/p\u003e\n\u003ch3\u003eLimitations\u003c/h3\u003e\n\u003cp\u003eHowever, certain limitations must be acknowledged. As with all observational studies, the possibility of unmeasured confounding cannot be fully excluded. The study was also restricted to a single region, which may limit generalizability. Additionally, incomplete pain score documentation in the Consultation group could introduce measurement bias. Future multicenter trials and registry-based surveillance are recommended to validate these findings across different EMS systems and to explore the role of alternative agents such as ketamine in paramedic-administered analgesia.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study supports the safe and effective administration of intravenous sufentanil by trained paramedics operating under a protocolized competency system. Compared with the traditional model requiring remote physician consultation, autonomous administration was associated with comparable safety, greater use of multimodal analgesia, and improved adherence to outcome documentation. These findings offer practical and evidence-based guidance for the potential expansion of paramedic scope of practice in the Czech Republic.\u003c/p\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eSupplemental Digital Content\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDetailed paramedics, baseline and efficacy, adverse event and physiologic values are mentioned in tables of supplemental digital content.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthor Contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRS\u003c/strong\u003e: Conceptualization; Methodology; Investigation, Data curation; Formal analysis; Writing - original draft; Project administration; \u003cstrong\u003eNK\u003c/strong\u003e: Data curation; Methodology; Writing \u0026ndash; review and editing; \u003cstrong\u003eOS\u003c/strong\u003e: Investigation; Writing \u0026ndash; review and editing; \u003cstrong\u003eDP\u003c/strong\u003e: Methodology and protocol; Writing \u0026ndash; review and editing; \u003cstrong\u003eJS\u003c/strong\u003e: Supervision; Writing -review and editing;\u003cstrong\u003e\u0026nbsp;MR\u003c/strong\u003e: Methodology; Writing \u0026ndash; review and editing; \u003cstrong\u003eMK:\u003c/strong\u003e Methodology; Supervision; Writing \u0026ndash; review and editing. Each author has been involved in drafting and critically revising the manuscript and has approved the final version for submission.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no external funding. The study was conducted entirely within\u0026nbsp;\u003cbr\u003e\u0026nbsp;the Emergency Medical Services of the Karlovy Vary Region, Czech Republic.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting Interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests related to this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthical Approval and Consent to Participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted in accordance with the ethical standards of the institutional\u0026nbsp;\u003cbr\u003e\u0026nbsp;and national research committee and with the 1964 Helsinki Declaration and its later amendments. Ethical approval was obtained from the relevant ethics committee. Informed consent was not required for this type of observational study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for Publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of Data and Materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analysed during the current study are available\u0026nbsp;\u003cbr\u003e\u0026nbsp;from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eUse of AI and AI-Assisted Technologies in the Writing Process\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring the preparation of this manuscript, the authors utilized ChatGPT (OpenAI) to assist in correcting English grammar and enhancing language clarity. All content was reviewed and edited by the authors to ensure accuracy and integrity. The authors take full responsibility for the content of the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eColding-J\u0026oslash;rgensen JT, Brandstrup GMG, Nielsen VML, Gradman J, Thybo LAB, Hansen PM, Wittrock D, Blomberg SNF, Christensen HC, Mikkelsen S. The use of strong analgesics for prehospital pain management in children in the region of Southern Denmark: a register-based study. Scand J Trauma Resusc Emerg Med. 2025;33(1):23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKiavialaitis GE, M\u0026uuml;ller S, Braun J, R\u0026ouml;ssler J, Spahn DR, Stein P, Kaserer A. Clinical practice of pre-hospital analgesia: An observational study of 20,978 missions in Switzerland. Am J Emerg Med. 2020;38(11):2318\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eScharonow M, Alberding T, Oltmanns W, Weilbach C. Project for the introduction of prehospital analgesia with fentanyl and morphine administered by specially trained paramedics in a rural service area in Germany. J Pain Res. 2017;10:2595\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRenza M, Sykora R, Peran D, Hricova K, Brizgalova N, Bakurova P, Kukacka M. Pilot implementation of the competence of Czech paramedics to administer sufentanil for the treatment of pain in acute trauma without consulting a physician: observational study. BMC Emerg Med. 2022;22(1):63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVilcane S, Scharonow O, Weilbach C, Scharonow M. Application of analgesics in emergency services in Germany: a survey of the medical directors. BMC Emerg Med. 2023;23(1):104.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHachimi-Idrissi S, Dobias V, Hautz WE, Leach R, Sauter TC, Sforzi I, et al. Approaching acute pain in emergency settings; European Society for Emergency Medicine (EUSEM) guidelines-part 2: management and recommendations. Intern Emerg Med. 2020;15(7):1141\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVilcane S, Scharonow O, Weilbach C, Scharonow M. Application of analgesics in emergency services in Germany: a survey of the medical directors. BMC Emerg Med. 2023;23(1):104. Erratum in: BMC Emerg Med. 2025;25(1):71. European Society for Emergency Medicine. Guidelines for the management of acute pain in emergency situations. March 2020. Accessed April 28, 2025. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.eusem.org/images/EUSEM_EPI_GUIDELINES_MARCH_2020.pdf\u003c/span\u003e\u003cspan address=\"https://www.eusem.org/images/EUSEM_EPI_GUIDELINES_MARCH_2020.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003evon Elm E, Altman DG, Egger M, Pocock SJ, G\u0026oslash;tzsche PC, Vandenbroucke JP, STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMinistry of Health of the Czech Republic. Decree No. 55/2011 Coll. on the activities of medical staff and other professionals. Collection of Laws of the Czech Republic; 2011.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFriesgaard KD, Vist GE, Hyldmo PK, Raatiniemi L, Kurola J, Larsen R, et al. Opioids for treatment of pre-hospital acute pain: a systematic review. Pain Ther. 2022;11(1):17\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDalton MK, Semco RS, Ordoobadi AJ, Goralnick E, Chovanes J, Salim A, et al. Opioid administration in the prehospital setting for patients sustaining traumatic injuries: an evaluation of national emergency medical services data. Injury. 2022;53(9):2923\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeslandes M, Deicke M, Grannemann JJ, Hinkelbein J, Hoyer A, Kalmbach M, et al. Effectiveness and safety of prehospital analgesia with nalbuphine and paracetamol versus morphine by paramedics: an observational study. Scand J Trauma Resusc Emerg Med. 2024;32(1):41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFriesgaard KD, Kirkegaard H, Rasmussen CH, Giebner M, Christensen EF, Nikolajsen L. Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols. Scand J Trauma Resusc Emerg Med. 2019;27(1):11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLe Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, et al. Ketamine compared with morphine for out-of-hospital analgesia for patients with traumatic pain: a randomized clinical trial. JAMA Netw Open. 2024;7(1):e2352844.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSandberg M, Hyldmo PK, Kongstad P, Dahl Friesgaard K, Raatiniemi L, Larsen R, Magnusson V, et al. Ketamine for the treatment of prehospital acute pain: a systematic review of benefit and harm. BMJ Open. 2020;10(11):e038134.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-trauma-and-emergency-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejot","sideBox":"Learn more about [European Journal of Trauma and Emergency Surgery](http://link.springer.com/journal/68)","snPcode":"68","submissionUrl":"https://submission.nature.com/new-submission/68/3","title":"European Journal of Trauma and Emergency Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"paramedic competencies, pre-hospital analgesia, opioid, sufentanil, low-severity trauma","lastPublishedDoi":"10.21203/rs.3.rs-6643859/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6643859/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground and importance\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn the Czech Republic, paramedics are required to consult a physician before administering intravenous opioids, which may delay effective prehospital pain management. As paramedic competencies expand in Europe, it is important to evaluate the safety and efficacy of independent opioid administration in real-world emergency medical settings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTo assess the safety and effectiveness of intravenous sufentanil administered independently by trained paramedics compared to administration following remote physician consultation in adult trauma patients.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eProspective, single-center, observational cohort study.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eSettings and participants\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eConducted at the Emergency Medical Services of the Karlovy Vary Region between January 1 and December 31, 2024. The study included 462 adult trauma patients who were hemodynamically stable and conscious. Patients were divided into two groups: the Consultation group (physician consultation required) and the Competency group (paramedics administering independently).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eIntervention or exposure\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIntravenous administration of sufentanil, with or without physician phone consultation.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eOutcome measures and analysis\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePrimary outcomes included reduction in pain (measured using the Numeric Rating Scale, NRS) and incidence of adverse events (e.g., respiratory depression, oxygen desaturation, hypotension, and antiemetic use). Statistical significance was set at p\u0026lt;0.05.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMain results\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBoth groups achieved similar pain reduction. The Competency group received a higher mean dose of sufentanil (9.7 ± 3.0 µg vs 8.9 ± 2.8 µg; p=0.006) and more frequently used non-opioid adjuvant analgesics (54% vs 41%). Documentation of pain scores was significantly better in the Competency group (87% vs 43%; p\u0026lt;0.01). Adverse events were rare, non-serious, and comparable between groups. Antiemetics were more frequently administered in the Competency group (11% vs 6%; p=0.037). A minor, clinically insignificant reduction in diastolic blood pressure was observed in the Competency group.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIndependent administration of intravenous sufentanil by trained paramedics was as safe and effective as physician-supervised administration, with better documentation and more frequent multimodal analgesia. These findings support expanding paramedic competencies in opioid analgesia within the Czech prehospital emergency system.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Intravenous Sufentanil Administration in Low-Severity Acute Trauma as A Competence of Paramedics: A Follow-Up Observational Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-14 10:59:10","doi":"10.21203/rs.3.rs-6643859/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-06-10T20:03:28+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-05T10:40:27+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-31T17:57:15+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-21T10:07:04+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"146681398625705401305456959382035785917","date":"2025-05-19T09:04:41+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"121383213535680612725377655180477239052","date":"2025-05-19T07:25:22+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"109360048494122298603131308637279493921","date":"2025-05-18T14:43:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-05-18T13:38:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-05-18T13:02:41+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-05-13T08:36:14+00:00","index":"","fulltext":""},{"type":"submitted","content":"European Journal of Trauma and Emergency Surgery","date":"2025-05-12T07:19:50+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-trauma-and-emergency-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejot","sideBox":"Learn more about [European Journal of Trauma and Emergency Surgery](http://link.springer.com/journal/68)","snPcode":"68","submissionUrl":"https://submission.nature.com/new-submission/68/3","title":"European Journal of Trauma and Emergency Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"50706670-bb55-4d62-b3d0-cf1b4def40e1","owner":[],"postedDate":"May 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-09-15T15:58:26+00:00","versionOfRecord":{"articleIdentity":"rs-6643859","link":"https://doi.org/10.1007/s00068-025-02953-0","journal":{"identity":"european-journal-of-trauma-and-emergency-surgery","isVorOnly":false,"title":"European Journal of Trauma and Emergency Surgery"},"publishedOn":"2025-09-09 15:57:01","publishedOnDateReadable":"September 9th, 2025"},"versionCreatedAt":"2025-05-14 10:59:10","video":"","vorDoi":"10.1007/s00068-025-02953-0","vorDoiUrl":"https://doi.org/10.1007/s00068-025-02953-0","workflowStages":[]},"version":"v1","identity":"rs-6643859","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6643859","identity":"rs-6643859","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}