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

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.