Polyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? A Randomized controlled clinical trial.

Polyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? 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A Randomized controlled clinical trial. Sepideh Jame Bozorgi, Nooshin Sajjadei, Mojtaba Hashemi, Marzieh Mohammadi Kharkeshi This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5122284/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Pediatric functional constipation is a prevalent issue that causes significant personal and societal burdens. While managing painful defecation is crucial in controlling the vicious cycle of stool withholding and altered rectal physiology, current approaches have addressed stool consistency rather than focusing on this critical outcome. Aim We aim to assess if adding paraffin to PEG affects painful defecation and other constipation outcomes in children with chronic functional constipation. Paraffin, with its lubricating mechanism, is hypothesized to improve stool passage and reduce pain during defecation. Methods We randomized 148 children with chronic functional constipation to receive either PEG plus paraffin or PEG alone for three months. We assessed painful defecation, number of defecation per week, and stool consistency as primary outcomes at baseline and after the intervention period. Secondary outcomes included nausea and vomiting, diarrhea, abdominal pain, and incontinence. We used the t-test, one-way analysis of variance (ANOVA), and repeated measures analysis to compare means in our data, and we used the chi-squared test to compare categorical data between groups. We utilized IBM SPSS Statistics 21 software for data analysis, and a p-value of 0.05 or lower was considered statistically significant. We also calculated effect sizes as mean difference and NNT in addition to their 95% confidence interval using MedCalc. Results Our study demonstrates that adding paraffin to PEG significantly improves painful defecation in children with chronic functional constipation. In contrast, it did not considerably impact stool consistency or the number of defecations. Conclusion Our findings suggest that paraffin can be a valuable adjunct to PEG in managing painful defecation, a crucial aspect of constipation treatment. Trial Registration The trial was registered at the Iranian Registry of Clinical Trials (irct.behdasht.gov.ir/trial/66979) with registration number ID IRCT20141209020258N179 on 01.01.2023. Health sciences/Health care/Paediatrics Health sciences/Health care/Paediatrics/Paediatric research chronic constipation childhood functional constipation polyethylene glycol paraffin treatment randomized controlled trial painful defecation Figures Figure 1 Figure 2 Background Functional constipation is a prominent issue within pediatric healthcare, contributing significantly to consultations. In the U.S., it accounts for about 3 percent of visits to general pediatricians but can rise to 25 percent when seen by specialized pediatric gastroenterologists. The worldwide occurrence of PFC varies widely according to research, ranging from 0.3 percent to 29.6 percent, without substantial gender differences. (1–4) Severity levels span from moderate and transient to severe and persistent, with roughly 25 percent of cases persisting into adulthood. Despite existing treatments, the standard of care remains constrained due to a need for more guidelines for managing this disorder, an ambiguous definition of its nature, and deficient evidence regarding pharmacological interventions. (5) To address childhood constipation, a combination of non-drug approaches and medications is applied. These non-pharmaceutical strategies encompass educational efforts, dispelling misconceptions, nutritional adjustments, potty training, behavior modification techniques, biofeedback, and pelvic floor exercises. On the other hand, pharmacological therapies, including osmotic laxatives like polyethylene glycol (PEG), lactulose, and milk of magnesia (MOM), are commonly used to manage functional constipation in children. These laxatives work by not being readily absorbed in the small intestine, causing them to retain water in the colon, thereby softening stools. On the other hand, alleviating pain during defecation is vital to prevent long-term complications associated with untreated or undertreated functional constipation. Still, the evidence for this important outcome needs to be more extensive. (6) Managing pain during episodes of constipation in children with functional constipation (FC) is crucial because it helps interrupt the vicious cycle of stool withholding, painful defecation, and altered rectal physiology. Stool withholding, frequently initiated by improper toilet training and uncomfortable bowel movements, leads to the accumulation of dry, hard fecal masses within the rectum. These fecal masses cause pain during elimination, encouraging continued withholding and potentially leading to mega Rectal dysfunction, characterized by an enlarged rectal capacity and reduced ability to expel stool, further reinforcing the pattern of stool withholding and painful defecation. Untreated or poorly managed FC can result in significant complications, highlighting the importance of addressing pain management strategies to improve outcomes for children suffering from constipation. (5) (7–9) Current treatments for painful defecation aim to address the underlying causes, such as constipation or anal fissures. Paraffin, also known as liquid paraffin, can help control painful defecation by lubricating the stool and easing its passage. Pathophysiologically, paraffin softens the stool, making it easier to pass without straining, which can reduce pain during defecation. However, its additional efficacy in pain reduction among children with functional constipation has not been empirically tested. (10) In this study, we aimed to assess the efficacy of adding paraffin to PEG in pain reduction and severity of constipation among children with chronic functional constipation. Methods Design and Participants This single-centered randomized controlled trial used a parallel design with a 1:1 allocation ratio. It was conducted independently, without any influence from commercial entities, in Amirkabir Hospital in Arak, Iran, from September 2022 to January 2023. One hundred forty-eight participants were randomly assigned to the intervention or comparison groups. The interventions consisted of either 0.7 g/kg/day Polyethylene Glycol (PEG) plus 0.7 ml/kg/day oral paraffin or 0.7 g/kg/day PEG alone for three months. The study included children aged 2–18 years who were diagnosed with functional constipation for at least three months. The diagnosis of functional constipation was based on Rome IV Criteria(Fig. 1 ). Exclusion criteria consisted of patients who had organic causes of constipation, individuals with known allergies to the study medications, those currently taking other medications for constipation, individuals with psychological or neurological disorders affecting bowel function, and those with concurrent systemic disorders that require specific treatment. Written informed consent was obtained from the patient's parents, and the study protocol was approved by Arak Medical University's ethics committee (IR.ARAKMU.REC.1401.109). It was registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) with registration number ID: IRCT20141209020258N179. Sample size and randomization The sample size was calculated based on the following formula: $$\:n=\frac{{\left({z}_{\left(1-\frac{a}{2}\right)}+{z}_{(1-\beta\:)}\right)}^{2}\left({\delta\:}_{1}^{2}+{\delta\:}_{2}^{2}\right)}{{\left({\mu\:}_{1-{\mu\:}_{2}}\right)}^{2}}$$ Confidence Level: 95% Power( \(\:\beta\:)\) : 80% Effect size( \(\:{\mu\:}_{1-{\mu\:}_{2}})\) : 0.4 $$\:{\delta\:}_{1}^{2}:1.49$$ $$\:{\delta\:}_{2}^{2}:0.64$$ Based on this formula and previous studies, each group's sample size was calculated as 74. We used Research Randomizer, a free online tool, and blocked randomization with a block size of 4 to randomly assign the included patients. The medications were prepared in identical packages and numbered consecutively according to the random sequence. The person who enrolled the participants was unaware of the randomization sequence. Blinding In the initial protocol for our trial, we intended to implement a single-blind design; however, this approach was ultimately not feasible due to the inherent differences in the forms of the interventions being administered. The study involved two distinct treatments: Pidrolax and Pidrolax combined with liquid paraffin. Given that these interventions were delivered in different formulations (i.e., one being a liquid medication and the other a liquid mixed with paraffin), it became apparent that blinding participants was not practical. The decision to forego blinding was made to ensure the integrity of the treatment administration process and to maintain clarity in participant understanding of their assigned intervention. This change was carefully considered, and we believe that it does not compromise the overall validity of our study findings. Instead, it allows for a more straightforward assessment of the outcomes associated with each treatment modality.We acknowledge that blinding is an important aspect of clinical trials; however, in this case, the differences in intervention forms necessitated this adjustment to the protocol. Outcome Assessment The primary outcome measures were stool consistency, frequency, and painful defecation. The secondary outcome measures consisted of adverse events, including encopresis, abdominal pain, nausea and vomiting, and diarrhea. Data were recorded in standardized data forms for each patient at baseline and on day 120 of the study. Patients in both groups underwent scheduled assessments at baseline (day 0) and the 120th day after enrollment. At the end of the study(day 120th), they were also inquired about adverse events during medication use. The person assessing the outcomes was unaware of the patients' assignments. However, patients were not masked. Statistical Analysis If the data were normally distributed, mean and standard deviation were used to present continuous variables. We used t-test, one-way analysis of variance (ANOVA), and Repeated measures analysis to compare means in our data. For categorical data, we used numbers and percentages to present data and the chi-squared test to compare groups. We utilized IBM SPSS Statistics 21 software for data analysis, and a p-value of 0.05 or lower was considered statistically significant. We calculated the mean difference and 95% confidence intervals as the effect size for the continuous outcomes using (Med Calc) based on the group’s mean, standard deviation, and sample size. We calculated NNT and its confidence interval for categorical outcomes based on the rate of patients who responded to the treatment in each group using an online calculator. (11) Results Participants At the beginning of the study, 160 patients were assessed for eligibility. A total of 12 patients were excluded; 2 of these patients declined to participate, 5 did not meet the inclusion criteria, and five did not participate for other reasons. Eligible participants were enrolled and randomly assigned to either PEG plus Paraffin or PEG treatment groups. Throughout the study, these 148 participants were regularly monitored for treatment compliance, adverse effects, and changes in their conditions. Notably, zero participants were lost to follow-up. Figure 2 illustrates a flow chart explaining the patients selected for analysis. Table 1: participants' baseline characteristics PEG + paraffin mean ± standard deviation PEG mean ± standard deviation Age (years) 6.29 ± 3.65 6.66 ± 3.3 Gender Male 30 (40.5%) 38 (51.4%) female 44 (59.5%) 36 (48.6%) Weight(kilograms) 23.41 ± 13.82 26.6 ± 13.52 Height(centimeters) 111.5 ± 18.95 118.5 ± 20.31 Duration of constipation (months) 14.73 ± 22.1 16.82 ± 22.07 Numbers of defecation (per week) 2.78 ± 2.22 2.77 ± 1.74 Painful defecation yes 66 (89.2%) 58 (78.4%) no 8 (10.8%) 16 (21.6%) Stool consistency Hard and lumpy 72 (97.3%) 73 (98.6%) Smooth 2 (2.7%) 1 (1.4%) loose 0 0 incontinency yes 9 (12.2%) 10 (13.5%) no 65 (87.8%) 64 (86.5%) Abdominal pain yes 67 (90.5%) 59 (79.7%) no 7 (9.5%) 15 (20.3%) History of laxative intake yes 12 (16.2%) 14 (18.9%) no 62 (83.8%) 60 (81.1%) The demographic and clinical characteristics of the two groups were similar. The PEG plus Paraffin group was slightly younger, with a mean age of 6.29 ± 3.65 than the PEG group, with a mean age of 6.66 ± 3.3. The difference was not statistically significant. The proportion of female and male participants was nearly equal. The average weight and height of both groups exhibited comparable values (table 1). Table 2: Results for primary outcomes PEG + paraffin mean ± standard deviation PEG mean ± standard deviation P value Numbers of Defecation (per week) 7.43 ± 3.31 7.09 ± 3.69 0.55 Painful defecation yes 1 (1.4%) 5 (6.8%) 0.02 no 73 (98.6%) 69 (93.2%) Stool consistency Hard And lumpy 3 (4.1%) 15 (20.3%) 0.001 smooth 41 (55.4%) 46 (62.2%) loose 30 (40.5%) 13 (17.6%) The addition of paraffin had a significant effect on decreasing the number of patients with painful defecation (NNT= 1.09, 95%CI: 1 to 1.2). Also, the rate of hard and lumpy stool consistency decreased significantly in the PEG+paraffin group(NNT= 6.17, 95%CI: 3.8 to 16.6 ). However, the number of defecation per week did not differ between the PEG + Paraffin and the PEG group at the end of the study(mean difference= 0.34 , 95%CI: -0.7989 to 1.4789)(Table 2). Table 3: Results for secondary outcomes PEG + paraffin mean PEG mean P value Stool incontinence yes 1 (1.4%) 1 (1.4%) 1 no 73 (98.6%) 73 (98.6%) Abdominal pain yes 5 (6.8%) 10 (13.5%) 0.17 no 69 (93.2%) 64 (86.5%) History of Laxative intake yes 12 (16.2%) 14 (18.9%) 0.66 no 62 (83.8%) 60 (81.1%) Nausea And vomiting yes 1 (1.4%) 1 (1.4%) 1 no 73 (98.6%) 73 (98.6%) diarrhea yes 4 (5.4%) 2 (2.7) 0.4 no 70 (94.6%) 72 (97.3) We also assessed adverse events during the study period. The rate of adverse events including stool incontinence, abdominal pain, nausea and vomiting, and diarrhea did not significantly differ between groups(table 3). Discussion We found that adding paraffin to PEG substantially decreased the rate of painful defecation compared to placebo in children with functional constipation. Adding paraffin to PEG also improved stool consistency compared to PEG alone. However, we did not find any additional benefit of adding paraffin to PEG on the number of defecations in children with constipation. Regarding safety, no difference was observed in the rate of adverse events between the paraffin + PEG and PEG alone groups. These findings show that adding paraffin can have a large effect on the rate of painful defecation and can improve stool consistency without causing any additional adverse events. We did not find any studies that were identical to our study. However, the most relevant study was by Moslemi Nia et al., where children were randomly assigned to two groups: one receiving polyethylene glycol-senna-paraffin (experimental group) and the other receiving polyethylene glycol-senna (control group). This study demonstrated that both routine and experimental treatments reduced abdominal and rectal pain, anal discomfort, and decreased stool diameter throughout the week, but adding paraffin to the combination of polyethylene glycol-senna in the treatment of functional constipation in children was effective in reducing the treatment duration. (12) In contrast with this study's findings, we found that adding paraffin reduced the rate of painful defecation. However, we did not assess the time required for the treatment response. This difference may be due to the addition, which may reduce painful defecation to an optimal level and make the addition of paraffin redundant. Another study investigated the benefit of adding castor oil as a lubricant to polyethylene glycol (PEG) for its potential to promote bowel evacuation. The results of this study indicated that PEG combined with castor oil is an effective and safe regimen for bowel cleansing and is relatively affordable, making it suitable for wider use. The study also found that the combination of these two drugs resulted in a decrease in PEG consumption. This study's findings align with our findings in that adding a lubricant facilitated bowel evacuation. (13) Another study that compared the efficacy of PEG 3350 and liquid paraffin showed no difference in treating chronic functional constipation in children. Both medications were found to be safe and effective in this age group. (10) In contrast with this study, another study comparing the effects of paraffin and polyethylene glycol (PEG) on pediatric bowel function showed a significant superiority of PEG in the number of bowel movements per week, encopresis, and rectal pain reduction. The study indicates that PEG is more effective than oral liquid paraffin for pediatric constipation. These studies compared the efficacy of PEG and paraffin. However, in our study, PEG was considered the baseline treatment in both groups, focusing on the benefit of combining PEG and paraffin(10). In contrast, another study that compared the efficacy of paraffin and PEG for functional constipation demonstrated that paraffin resulted in a better therapeutic effect in children younger than three years. Our randomized controlled trial on the efficacy of adding paraffin to PEG for functional constipation in children is valuable due to its practical significance in evaluating pain as an essential outcome in children's functional constipation. This trial is the first to focus on pain as a primary outcome and the first to assess the effect of the combination of PEG and paraffin compared to PEG alone. As a pediatric laxative, liquid paraffin has been widely accepted for managing childhood constipation. The drug acts primarily as a stool lubricant, reducing the pain caused by certain conditions such as piles (hemorrhoids), making it an ideal treatment for chronic childhood constipation and encopresis when large doses or long-term usage is necessary. The study's limitations include the lack of blinding, which may introduce bias, and the relatively short follow-up period, which may underestimate the effects of adding paraffin. Given the differential impacts of laxatives in different age groups, the study would have benefited from subgroup analyses for age groups if the sample size had sufficed. CONCLUSION This study showed that adding paraffin to PEG safely and substantially reduced painful defecation and improved stool consistency among children with chronic functional constipation without any additional benefit in reducing the severity of constipation. Abbreviations PEG - Polyethylene Glycol ANOVA - Analysis of Variance NNT - Numbers Needed to Treat FC - Functional Constipation MOM - Milk of Magnesia IR - Iranian Registry IRCT - Iranian Registry of Clinical Trials PFC - Pediatric Functional Constipation Declarations Ethics approval and consent to participate Written informed consent was obtained from the patient's parents provided written informed consent, and the study protocol was approved by Arak Medical University's ethics committee (IR.ARAKMU.REC.1401.109). We confirm that all methods employed in this study were conducted in accordance with the relevant guidelines and regulations. Specifically, all procedures involving human participants adhered to the ethical standards set forth by the institutional and national research committees, as well as the principles outlined in the 1964 Helsinki Declaration and its subsequent amendments. Additionally, informed consent was obtained from all individual participants involved in the study, ensuring that their rights and welfare were prioritized throughout the research process. Consent for publication All authors read and approved the final manuscript. Availability of data and materials The data supporting the findings of the study titled "Polyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? A Randomized controlled clinical trial" are available upon reasonable request from the corresponding author, Nooshin Sajjadei ( [email protected] ). The original data generated during this research, including participant demographics and outcomes related to painful defecation and stool consistency, will be provided in a de-identified format to protect participant privacy. Competing interests The authors declare that they have no competing interests. Funding No funding was received for this study. Authors' contributions SJB, NS, and MH- were all involved in the study design, conduction, and data analysis. SJB was also involved in data collection and manuscript drafting. All authors read and approved the final manuscript. Acknowledgments We would like to thank the children and their families for their cooperation in this study. References Hussain SZ, Labrum B, Mareya S, Stripling S, Clifford R. Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial. J Pediatr Gastroenterol Nutr. 2021;73(5):572-8. Mozaffarpur SA, Naseri M, Esmaeilidooki MR, Kamalinejad M, Bijani A. The effect of cassia fistula emulsion on pediatric functional constipation in comparison with mineral oil: a randomized, clinical trial. Daru. 2012;20(1):83. Hartman EE, Pawaskar M, Williams V, McLeod L, Dubois D, Benninga MA, Joseph A. Psychometric properties of PedsQL generic core scales for children with functional constipation in the Netherlands. J Pediatr Gastroenterol Nutr. 2014;59(6):739-47. Caputi V, Hill L, Figueiredo M, Popov J, Hartung E, Margolis KG, et al. Functional contribution of the intestinal microbiome in autism spectrum disorder, attention deficit hyperactivity disorder, and Rett syndrome: a systematic review of pediatric and adult studies. Front Neurosci. 2024;18:1341656. Sood M, Lichtlen P, Perez MC. Unmet Needs in Pediatric Functional Constipation. Clin Pediatr (Phila). 2018;57(13):1489-95. Tran DL, Sintusek P. Functional constipation in children: What physicians should know. World J Gastroenterol. 2023;29(8):1261-88. Hanin Ahmed M, Ali I, Ali MM. Effectiveness of Polyethylene Glycol 3350 versus Lactulose in Management of Functional Constipation in Children. International Journal of Pediatric Research. 2022. Thompson AP, MacDonald SE, Wine E, Scott SD. Understanding Parents' Experiences When Caring for a Child With Functional Constipation: Interpretive Description Study. JMIR Pediatr Parent. 2021;4(1):e24851. Seth R, Heyman MB. Management of constipation and encopresis in infants and children. Gastroenterol Clin North Am. 1994;23(4):621-36. Rafati M, Karami H, Salehifar E, Karimzadeh A. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation. Daru. 2011;19(2):154-8. . MedCalc Statistical Software version 1926 (MedCalc Software bv, Ostend, Belgium; https://wwwmedcalcorg; 2020)" from the text box into your manuscript Evaluating the Effect of Adding Paraffin to the Polyethylene Glycol-Senna Combination Therapy for the Treatment of Functional Constipation: Yazd Azad University; 1392. Xiong Z, Fang Y, Feng F, Cheng Y, Huo C, Huang J. 2L polyethylene glycol combined with castor oil versus 4L polyethylene glycol for bowel preparation before colonoscopy among inpatients. Medicine (Baltimore). 2023;102(29):e34294. Additional Declarations No competing interests reported. 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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-5122284","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":365031858,"identity":"d748fafa-6f4b-442f-b9fc-2fda6276d5ae","order_by":0,"name":"Sepideh Jame Bozorgi","email":"","orcid":"","institution":"Arak University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Sepideh","middleName":"Jame","lastName":"Bozorgi","suffix":""},{"id":365031859,"identity":"329152e9-35c7-4769-9c9e-fce882b31bcb","order_by":1,"name":"Nooshin Sajjadei","email":"data:image/png;base64,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","orcid":"","institution":"Arak University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Nooshin","middleName":"","lastName":"Sajjadei","suffix":""},{"id":365031860,"identity":"cb73432e-5a20-4d3b-b996-2fc93672a73d","order_by":2,"name":"Mojtaba Hashemi","email":"","orcid":"","institution":"Arak University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mojtaba","middleName":"","lastName":"Hashemi","suffix":""},{"id":365031861,"identity":"17713919-03a9-4636-bbfb-c5e50d652ec8","order_by":3,"name":"Marzieh Mohammadi Kharkeshi","email":"","orcid":"","institution":"Arak University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Marzieh","middleName":"Mohammadi","lastName":"Kharkeshi","suffix":""}],"badges":[],"createdAt":"2024-09-20 09:06:55","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5122284/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5122284/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":67203472,"identity":"e28d53db-4bb1-4903-b6f1-97eb27a33117","added_by":"auto","created_at":"2024-10-22 10:29:08","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":76733,"visible":true,"origin":"","legend":"\u003cp\u003eRome IV Criteria\u003c/p\u003e","description":"","filename":"figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-5122284/v1/2fd38dda315f744294ddca96.png"},{"id":67202733,"identity":"29f71655-0d5c-46b7-a685-835d706e3dd0","added_by":"auto","created_at":"2024-10-22 10:21:08","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":51440,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT participants' flow diagram\u003c/p\u003e","description":"","filename":"figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-5122284/v1/dbb9395b8e3017daeefe9e55.png"},{"id":77352902,"identity":"2c69598f-a06e-4602-bd90-a02a4dc9b348","added_by":"auto","created_at":"2025-02-27 17:16:43","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":697553,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5122284/v1/44494bad-6f9a-4aa8-9eb9-9fd3ad10eeca.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003ePolyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? A Randomized controlled clinical trial.\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eFunctional constipation is a prominent issue within pediatric healthcare, contributing significantly to consultations. In the U.S., it accounts for about 3 percent of visits to general pediatricians but can rise to 25 percent when seen by specialized pediatric gastroenterologists. The worldwide occurrence of PFC varies widely according to research, ranging from 0.3 percent to 29.6 percent, without substantial gender differences. (1–4) Severity levels span from moderate and transient to severe and persistent, with roughly 25 percent of cases persisting into adulthood. Despite existing treatments, the standard of care remains constrained due to a need for more guidelines for managing this disorder, an ambiguous definition of its nature, and deficient evidence regarding pharmacological interventions. (5)\u003c/p\u003e \u003cp\u003eTo address childhood constipation, a combination of non-drug approaches and medications is applied. These non-pharmaceutical strategies encompass educational efforts, dispelling misconceptions, nutritional adjustments, potty training, behavior modification techniques, biofeedback, and pelvic floor exercises. On the other hand, pharmacological therapies, including osmotic laxatives like polyethylene glycol (PEG), lactulose, and milk of magnesia (MOM), are commonly used to manage functional constipation in children. These laxatives work by not being readily absorbed in the small intestine, causing them to retain water in the colon, thereby softening stools. On the other hand, alleviating pain during defecation is vital to prevent long-term complications associated with untreated or undertreated functional constipation. Still, the evidence for this important outcome needs to be more extensive. (6)\u003c/p\u003e \u003cp\u003eManaging pain during episodes of constipation in children with functional constipation (FC) is crucial because it helps interrupt the vicious cycle of stool withholding, painful defecation, and altered rectal physiology. Stool withholding, frequently initiated by improper toilet training and uncomfortable bowel movements, leads to the accumulation of dry, hard fecal masses within the rectum. These fecal masses cause pain during elimination, encouraging continued withholding and potentially leading to mega Rectal dysfunction, characterized by an enlarged rectal capacity and reduced ability to expel stool, further reinforcing the pattern of stool withholding and painful defecation. Untreated or poorly managed FC can result in significant complications, highlighting the importance of addressing pain management strategies to improve outcomes for children suffering from constipation. (5) (7–9)\u003c/p\u003e \u003cp\u003eCurrent treatments for painful defecation aim to address the underlying causes, such as constipation or anal fissures. Paraffin, also known as liquid paraffin, can help control painful defecation by lubricating the stool and easing its passage. Pathophysiologically, paraffin softens the stool, making it easier to pass without straining, which can reduce pain during defecation. However, its additional efficacy in pain reduction among children with functional constipation has not been empirically tested. (10)\u003c/p\u003e \u003cp\u003eIn this study, we aimed to assess the efficacy of adding paraffin to PEG in pain reduction and severity of constipation among children with chronic functional constipation.\u003c/p\u003e "},{"header":"Methods","content":"\u003ch2\u003eDesign and Participants\u003c/h2\u003e\n\u003cp\u003eThis single-centered randomized controlled trial used a parallel design with a 1:1 allocation ratio. It was conducted independently, without any influence from commercial entities, in Amirkabir Hospital in Arak, Iran, from September 2022 to January 2023. One hundred forty-eight participants were randomly assigned to the intervention or comparison groups. The interventions consisted of either 0.7 g/kg/day Polyethylene Glycol (PEG) plus 0.7 ml/kg/day oral paraffin or 0.7 g/kg/day PEG alone for three months.\u003c/p\u003e\n\u003cp\u003eThe study included children aged 2\u0026ndash;18 years who were diagnosed with functional constipation for at least three months. The diagnosis of functional constipation was based on Rome IV Criteria(Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). Exclusion criteria consisted of patients who had organic causes of constipation, individuals with known allergies to the study medications, those currently taking other medications for constipation, individuals with psychological or neurological disorders affecting bowel function, and those with concurrent systemic disorders that require specific treatment.\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from the patient\u0026apos;s parents, and the study protocol was approved by Arak Medical University\u0026apos;s ethics committee (IR.ARAKMU.REC.1401.109). It was registered at the Iranian Registry of Clinical Trials (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.irct.ir\u003c/span\u003e\u003c/span\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e)\u003c/span\u003e with registration number ID: IRCT20141209020258N179.\u003c/p\u003e\n\u003ch2\u003eSample size and randomization\u003c/h2\u003e\n\u003cp\u003eThe sample size was calculated based on the following formula:\u003c/p\u003e\n\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e$$\\:n=\\frac{{\\left({z}_{\\left(1-\\frac{a}{2}\\right)}+{z}_{(1-\\beta\\:)}\\right)}^{2}\\left({\\delta\\:}_{1}^{2}+{\\delta\\:}_{2}^{2}\\right)}{{\\left({\\mu\\:}_{1-{\\mu\\:}_{2}}\\right)}^{2}}$$\u003c/div\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\n \u003cp\u003eConfidence Level: 95%\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003ePower(\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:\\beta\\:)\\)\u003c/span\u003e\u003c/span\u003e: 80%\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eEffect size(\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:{\\mu\\:}_{1-{\\mu\\:}_{2}})\\)\u003c/span\u003e\u003c/span\u003e: 0.4\u003c/p\u003e\n \u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv id=\"Equb\" class=\"Equation\"\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equb\" name=\"EquationSource\"\u003e$$\\:{\\delta\\:}_{1}^{2}:1.49$$\u003c/div\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Equc\" class=\"Equation\"\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equc\" name=\"EquationSource\"\u003e$$\\:{\\delta\\:}_{2}^{2}:0.64$$\u003c/div\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n\u003c/div\u003e\n\u003cp\u003eBased on this formula and previous studies, each group\u0026apos;s sample size was calculated as 74. We used Research Randomizer, a free online tool, and blocked randomization with a block size of 4 to randomly assign the included patients. The medications were prepared in identical packages and numbered consecutively according to the random sequence. The person who enrolled the participants was unaware of the randomization sequence.\u003c/p\u003e\n\u003ch2\u003eBlinding\u003c/h2\u003e\n\u003cp\u003eIn the initial protocol for our trial, we intended to implement a single-blind design; however, this approach was ultimately not feasible due to the inherent differences in the forms of the interventions being administered. The study involved two distinct treatments: Pidrolax and Pidrolax combined with liquid paraffin. Given that these interventions were delivered in different formulations (i.e., one being a liquid medication and the other a liquid mixed with paraffin), it became apparent that blinding participants was not practical. The decision to forego blinding was made to ensure the integrity of the treatment administration process and to maintain clarity in participant understanding of their assigned intervention. This change was carefully considered, and we believe that it does not compromise the overall validity of our study findings. Instead, it allows for a more straightforward assessment of the outcomes associated with each treatment modality.We acknowledge that blinding is an important aspect of clinical trials; however, in this case, the differences in intervention forms necessitated this adjustment to the protocol.\u003c/p\u003e\n\u003ch2\u003eOutcome Assessment\u003c/h2\u003e\n\u003cp\u003eThe primary outcome measures were stool consistency, frequency, and painful defecation. The secondary outcome measures consisted of adverse events, including encopresis, abdominal pain, nausea and vomiting, and diarrhea. Data were recorded in standardized data forms for each patient at baseline and on day 120 of the study.\u003c/p\u003e\n\u003cp\u003ePatients in both groups underwent scheduled assessments at baseline (day 0) and the 120th day after enrollment. At the end of the study(day 120th), they were also inquired about adverse events during medication use. The person assessing the outcomes was unaware of the patients\u0026apos; assignments. However, patients were not masked.\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical Analysis\u003c/h2\u003e\n \u003cp\u003eIf the data were normally distributed, mean and standard deviation were used to present continuous variables. We used t-test, one-way analysis of variance (ANOVA), and Repeated measures analysis to compare means in our data. For categorical data, we used numbers and percentages to present data and the chi-squared test to compare groups. We utilized IBM SPSS Statistics 21 software for data analysis, and a p-value of 0.05 or lower was considered statistically significant.\u003c/p\u003e\n \u003cp\u003eWe calculated the mean difference and 95% confidence intervals as the effect size for the continuous outcomes using (Med Calc) based on the group\u0026rsquo;s mean, standard deviation, and sample size.\u003c/p\u003e\n \u003cp\u003eWe calculated NNT and its confidence interval for categorical outcomes based on the rate of patients who responded to the treatment in each group using an online calculator. (11)\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eParticipants\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt the beginning of the study, 160 patients were assessed for eligibility. A total of 12 patients were excluded; 2 of these patients declined to participate, 5 did not meet the inclusion criteria, and five did not participate for other reasons. Eligible participants were enrolled and randomly assigned to either PEG plus Paraffin or PEG treatment groups. Throughout the study, these 148 participants were regularly monitored for treatment compliance, adverse effects, and changes in their conditions. Notably, zero participants were lost to follow-up. Figure 2 illustrates a flow chart explaining the patients selected for analysis.\u003c/p\u003e\n\u003cp\u003eTable 1: participants\u0026apos; baseline characteristics\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003ePEG + paraffin\u003c/p\u003e\n \u003cp\u003emean \u0026plusmn; standard deviation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003ePEG\u003c/p\u003e\n \u003cp\u003emean \u0026plusmn; standard deviation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003eAge (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e6.29 \u0026plusmn; 3.65\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e6.66 \u0026plusmn; 3.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003cstrong\u003eGender \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e30 (40.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e38 (51.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003efemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e44 (59.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e36 (48.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003eWeight(kilograms)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e23.41 \u0026plusmn; 13.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e26.6 \u0026plusmn; 13.52\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003eHeight(centimeters)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e111.5 \u0026plusmn; 18.95\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e118.5 \u0026plusmn; 20.31\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003eDuration of constipation\u003c/p\u003e\n \u003cp\u003e(months)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e14.73 \u0026plusmn; 22.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e16.82 \u0026plusmn; 22.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 58%;\"\u003e\n \u003cp\u003eNumbers of defecation\u003c/p\u003e\n \u003cp\u003e(per week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e2.78 \u0026plusmn; 2.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e2.77 \u0026plusmn; 1.74\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003ePainful defecation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e66 (89.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e58 (78.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e8 (10.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e16 (21.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Stool consistency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eHard and lumpy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e72 (97.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eSmooth\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e2 (2.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eloose\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003eincontinency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp dir=\"RTL\"\u003e\u003cspan dir=\"LTR\"\u003e9 (12.2%)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e10 (13.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e65 (87.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e64 (86.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003eAbdominal pain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e67 (90.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e59 (79.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e7 (9.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e15 (20.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 43%;\"\u003e\n \u003cp\u003eHistory of laxative intake\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e12 (16.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e14 (18.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15%;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e62 (83.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20%;\"\u003e\n \u003cp\u003e60 (81.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe demographic and clinical characteristics of the two groups were similar. The PEG plus Paraffin group was slightly younger, with a mean age of 6.29 \u0026plusmn; 3.65 than the PEG group, with a mean age of 6.66 \u0026plusmn; 3.3. The difference was not statistically significant. The proportion of female and male participants was nearly equal. The average weight and height of both groups exhibited comparable values (table 1).\u003c/p\u003e\n\u003cp\u003eTable 2: Results for primary outcomes\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"425\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003ePEG + paraffin\u003c/p\u003e\n \u003cp\u003emean \u0026plusmn; standard deviation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003ePEG\u003c/p\u003e\n \u003cp\u003emean \u0026plusmn; standard deviation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 54px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eNumbers of\u003c/p\u003e\n \u003cp\u003eDefecation\u003c/p\u003e\n \u003cp\u003e(per week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7.43 \u0026plusmn; 3.31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7.09 \u0026plusmn; 3.69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 54px;\"\u003e\n \u003cp\u003e0.55\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003ePainful\u003c/p\u003e\n \u003cp\u003edefecation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e5 (6.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 54px;\"\u003e\n \u003cp\u003e0.02\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e69 (93.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 89px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eStool\u003c/p\u003e\n \u003cp\u003econsistency\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003eHard\u003c/p\u003e\n \u003cp\u003eAnd\u003c/p\u003e\n \u003cp\u003elumpy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e3 (4.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e15 (20.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 54px;\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003esmooth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e41 (55.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e46 (62.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 62px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eloose\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e30 (40.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 110px;\"\u003e\n \u003cp\u003e13 (17.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe addition of paraffin had a significant effect on decreasing the number of patients with painful defecation (NNT= 1.09, 95%CI: 1 to 1.2). Also, the rate of hard and lumpy stool consistency decreased significantly in the PEG+paraffin group(NNT= 6.17, 95%CI: 3.8 to 16.6 ). However, the number of defecation per week did not differ between the PEG + Paraffin and the PEG group at the end of the study(mean difference= 0.34\u0026nbsp;\u003cbr\u003e\u0026nbsp;, 95%CI: -0.7989 to 1.4789)(Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 3: Results for secondary outcomes\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"393\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 133px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003ePEG + paraffin\u003c/p\u003e\n \u003cp\u003emean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003ePEG\u003c/p\u003e\n \u003cp\u003emean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 97px;\"\u003e\n \u003cp\u003eStool\u003c/p\u003e\n \u003cp\u003eincontinence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 97px;\"\u003e\n \u003cp\u003eAbdominal\u003c/p\u003e\n \u003cp\u003epain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e5 (6.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e10 (13.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e0.17\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e69 (93.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e64 (86.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 97px;\"\u003e\n \u003cp\u003eHistory of\u003c/p\u003e\n \u003cp\u003eLaxative\u003c/p\u003e\n \u003cp\u003eintake\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e12 (16.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e14 (18.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e0.66\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e62 (83.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e60 (81.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 97px;\"\u003e\n \u003cp\u003eNausea\u003c/p\u003e\n \u003cp\u003eAnd\u003c/p\u003e\n \u003cp\u003evomiting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e1 (1.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e73 (98.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 97px;\"\u003e\n \u003cp\u003ediarrhea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e4 (5.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e2 (2.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 61px;\"\u003e\n \u003cp\u003e0.4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 112px;\"\u003e\n \u003cp\u003e70 (94.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 86px;\"\u003e\n \u003cp\u003e72 (97.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eWe also assessed adverse events during the study period. The rate of adverse events including stool incontinence, abdominal pain, nausea and vomiting, and diarrhea did not significantly differ between groups(table 3).\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe found that adding paraffin to PEG substantially decreased the rate of painful defecation compared to placebo in children with functional constipation. Adding paraffin to PEG also improved stool consistency compared to PEG alone. However, we did not find any additional benefit of adding paraffin to PEG on the number of defecations in children with constipation. Regarding safety, no difference was observed in the rate of adverse events between the paraffin\u0026thinsp;+\u0026thinsp;PEG and PEG alone groups. These findings show that adding paraffin can have a large effect on the rate of painful defecation and can improve stool consistency without causing any additional adverse events.\u003c/p\u003e \u003cp\u003eWe did not find any studies that were identical to our study. However, the most relevant study was by Moslemi Nia et al., where children were randomly assigned to two groups: one receiving polyethylene glycol-senna-paraffin (experimental group) and the other receiving polyethylene glycol-senna (control group). This study demonstrated that both routine and experimental treatments reduced abdominal and rectal pain, anal discomfort, and decreased stool diameter throughout the week, but adding paraffin to the combination of polyethylene glycol-senna in the treatment of functional constipation in children was effective in reducing the treatment duration. (12) In contrast with this study's findings, we found that adding paraffin reduced the rate of painful defecation. However, we did not assess the time required for the treatment response. This difference may be due to the addition, which may reduce painful defecation to an optimal level and make the addition of paraffin redundant.\u003c/p\u003e \u003cp\u003eAnother study investigated the benefit of adding castor oil as a lubricant to polyethylene glycol (PEG) for its potential to promote bowel evacuation. The results of this study indicated that PEG combined with castor oil is an effective and safe regimen for bowel cleansing and is relatively affordable, making it suitable for wider use. The study also found that the combination of these two drugs resulted in a decrease in PEG consumption. This study's findings align with our findings in that adding a lubricant facilitated bowel evacuation. (13)\u003c/p\u003e \u003cp\u003eAnother study that compared the efficacy of PEG 3350 and liquid paraffin showed no difference in treating chronic functional constipation in children. Both medications were found to be safe and effective in this age group. (10) In contrast with this study, another study comparing the effects of paraffin and polyethylene glycol (PEG) on pediatric bowel function showed a significant superiority of PEG in the number of bowel movements per week, encopresis, and rectal pain reduction. The study indicates that PEG is more effective than oral liquid paraffin for pediatric constipation. These studies compared the efficacy of PEG and paraffin. However, in our study, PEG was considered the baseline treatment in both groups, focusing on the benefit of combining PEG and paraffin(10). In contrast, another study that compared the efficacy of paraffin and PEG for functional constipation demonstrated that paraffin resulted in a better therapeutic effect in children younger than three years.\u003c/p\u003e \u003cp\u003eOur randomized controlled trial on the efficacy of adding paraffin to PEG for functional constipation in children is valuable due to its practical significance in evaluating pain as an essential outcome in children's functional constipation. This trial is the first to focus on pain as a primary outcome and the first to assess the effect of the combination of PEG and paraffin compared to PEG alone. As a pediatric laxative, liquid paraffin has been widely accepted for managing childhood constipation. The drug acts primarily as a stool lubricant, reducing the pain caused by certain conditions such as piles (hemorrhoids), making it an ideal treatment for chronic childhood constipation and encopresis when large doses or long-term usage is necessary.\u003c/p\u003e \u003cp\u003eThe study's limitations include the lack of blinding, which may introduce bias, and the relatively short follow-up period, which may underestimate the effects of adding paraffin. Given the differential impacts of laxatives in different age groups, the study would have benefited from subgroup analyses for age groups if the sample size had sufficed.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThis study showed that adding paraffin to PEG safely and substantially reduced painful defecation and improved stool consistency among children with chronic functional constipation without any additional benefit in reducing the severity of constipation.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003ePEG - Polyethylene Glycol\u003c/li\u003e\n \u003cli\u003eANOVA - Analysis of Variance\u003c/li\u003e\n \u003cli\u003eNNT - Numbers Needed to Treat\u003c/li\u003e\n \u003cli\u003eFC - Functional Constipation\u003c/li\u003e\n \u003cli\u003eMOM - Milk of Magnesia\u003c/li\u003e\n \u003cli\u003eIR - Iranian Registry\u003c/li\u003e\n \u003cli\u003eIRCT - Iranian Registry of Clinical Trials\u003c/li\u003e\n \u003cli\u003ePFC - Pediatric Functional Constipation\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eWritten informed consent was obtained from the patient\u0026apos;s parents provided written informed consent, and the study protocol was approved by Arak Medical University\u0026apos;s ethics committee (IR.ARAKMU.REC.1401.109).\u003c/p\u003e\n\u003cp\u003eWe confirm that all methods employed in this study were conducted in accordance with the relevant guidelines and regulations. Specifically, all procedures involving human participants adhered to the ethical standards set forth by the institutional and national research committees, as well as the principles outlined in the 1964 Helsinki Declaration and its subsequent amendments. Additionally, informed consent was obtained from all individual participants involved in the study, ensuring that their rights and welfare were prioritized throughout the research process.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eAll authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eThe data supporting the findings of the study titled \u0026quot;Polyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? A Randomized controlled clinical trial\u0026quot; are available upon reasonable request from the corresponding author, Nooshin Sajjadei \u0026nbsp;([email protected]).\u003c/p\u003e\n\u003cp\u003eThe original data generated during this research, including participant demographics and outcomes related to painful defecation and stool consistency, will be provided in a de-identified format to protect participant privacy.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eNo funding was received for this study.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026apos; contributions\u003c/h2\u003e\n\u003cp\u003eSJB, NS, and MH- were all involved in the study design, conduction, and data analysis. SJB was also involved in data collection and manuscript drafting. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgments\u003c/h2\u003e\n\u003cp\u003eWe would like to thank the children and their families for their cooperation in this study.\u003c/p\u003e\n\u003ch2\u003e\u0026nbsp;\u003c/h2\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHussain SZ, Labrum B, Mareya S, Stripling S, Clifford R. Safety of Lubiprostone in Pediatric Patients With Functional Constipation: A Nonrandomized, Open-Label Trial. J Pediatr Gastroenterol Nutr. 2021;73(5):572-8.\u003c/li\u003e\n\u003cli\u003eMozaffarpur SA, Naseri M, Esmaeilidooki MR, Kamalinejad M, Bijani A. The effect of cassia fistula emulsion on pediatric functional constipation in comparison with mineral oil: a randomized, clinical trial. Daru. 2012;20(1):83.\u003c/li\u003e\n\u003cli\u003eHartman EE, Pawaskar M, Williams V, McLeod L, Dubois D, Benninga MA, Joseph A. Psychometric properties of PedsQL generic core scales for children with functional constipation in the Netherlands. J Pediatr Gastroenterol Nutr. 2014;59(6):739-47.\u003c/li\u003e\n\u003cli\u003eCaputi V, Hill L, Figueiredo M, Popov J, Hartung E, Margolis KG, et al. Functional contribution of the intestinal microbiome in autism spectrum disorder, attention deficit hyperactivity disorder, and Rett syndrome: a systematic review of pediatric and adult studies. Front Neurosci. 2024;18:1341656.\u003c/li\u003e\n\u003cli\u003eSood M, Lichtlen P, Perez MC. Unmet Needs in Pediatric Functional Constipation. Clin Pediatr (Phila). 2018;57(13):1489-95.\u003c/li\u003e\n\u003cli\u003eTran DL, Sintusek P. Functional constipation in children: What physicians should know. World J Gastroenterol. 2023;29(8):1261-88.\u003c/li\u003e\n\u003cli\u003eHanin Ahmed M, Ali I, Ali MM. Effectiveness of Polyethylene Glycol 3350 versus Lactulose in Management of Functional Constipation in Children. International Journal of Pediatric Research. 2022.\u003c/li\u003e\n\u003cli\u003eThompson AP, MacDonald SE, Wine E, Scott SD. Understanding Parents\u0026apos; Experiences When Caring for a Child With Functional Constipation: Interpretive Description Study. JMIR Pediatr Parent. 2021;4(1):e24851.\u003c/li\u003e\n\u003cli\u003eSeth R, Heyman MB. Management of constipation and encopresis in infants and children. Gastroenterol Clin North Am. 1994;23(4):621-36.\u003c/li\u003e\n\u003cli\u003eRafati M, Karami H, Salehifar E, Karimzadeh A. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation. Daru. 2011;19(2):154-8.\u003c/li\u003e\n\u003cli\u003e. MedCalc Statistical Software version 1926 (MedCalc Software bv, Ostend, Belgium; https://wwwmedcalcorg; 2020)\u0026quot; from the text box into your manuscript \u003c/li\u003e\n\u003cli\u003eEvaluating the Effect of Adding Paraffin to the Polyethylene Glycol-Senna Combination Therapy for the Treatment of Functional Constipation: Yazd Azad University; 1392.\u003c/li\u003e\n\u003cli\u003eXiong Z, Fang Y, Feng F, Cheng Y, Huo C, Huang J. 2L polyethylene glycol combined with castor oil versus 4L polyethylene glycol for bowel preparation before colonoscopy among inpatients. Medicine (Baltimore). 2023;102(29):e34294.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"chronic constipation, childhood, functional constipation, polyethylene glycol, paraffin, treatment, randomized controlled trial, painful defecation","lastPublishedDoi":"10.21203/rs.3.rs-5122284/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5122284/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePediatric functional constipation is a prevalent issue that causes significant personal and societal burdens. While managing painful defecation is crucial in controlling the vicious cycle of stool withholding and altered rectal physiology, current approaches have addressed stool consistency rather than focusing on this critical outcome.\u003c/p\u003e\u003ch2\u003eAim\u003c/h2\u003e \u003cp\u003eWe aim to assess if adding paraffin to PEG affects painful defecation and other constipation outcomes in children with chronic functional constipation. Paraffin, with its lubricating mechanism, is hypothesized to improve stool passage and reduce pain during defecation.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe randomized 148 children with chronic functional constipation to receive either PEG plus paraffin or PEG alone for three months. We assessed painful defecation, number of defecation per week, and stool consistency as primary outcomes at baseline and after the intervention period. Secondary outcomes included nausea and vomiting, diarrhea, abdominal pain, and incontinence. We used the t-test, one-way analysis of variance (ANOVA), and repeated measures analysis to compare means in our data, and we used the chi-squared test to compare categorical data between groups. We utilized IBM SPSS Statistics 21 software for data analysis, and a p-value of 0.05 or lower was considered statistically significant. We also calculated effect sizes as mean difference and NNT in addition to their 95% confidence interval using MedCalc.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOur study demonstrates that adding paraffin to PEG significantly improves painful defecation in children with chronic functional constipation. In contrast, it did not considerably impact stool consistency or the number of defecations.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eOur findings suggest that paraffin can be a valuable adjunct to PEG in managing painful defecation, a crucial aspect of constipation treatment.\u003c/p\u003e\u003ch2\u003eTrial Registration\u003c/h2\u003e \u003cp\u003eThe trial was registered at the Iranian Registry of Clinical Trials (irct.behdasht.gov.ir/trial/66979) with registration number ID IRCT20141209020258N179 on 01.01.2023.\u003c/p\u003e","manuscriptTitle":"Polyethylene glycol plus paraffin vs. Polyethylene glycol alone: Which is more effective in treating pediatric functional constipation? A Randomized controlled clinical trial.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-10-22 10:21:03","doi":"10.21203/rs.3.rs-5122284/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"084f2588-18f2-4b77-b6b2-8b6322e175e4","owner":[],"postedDate":"October 22nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":38951954,"name":"Health sciences/Health care/Paediatrics"},{"id":38951955,"name":"Health sciences/Health care/Paediatrics/Paediatric research"}],"tags":[],"updatedAt":"2025-02-27T17:08:35+00:00","versionOfRecord":[],"versionCreatedAt":"2024-10-22 10:21:03","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5122284","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5122284","identity":"rs-5122284","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}