Document Type : original article

Authors

1 Department of Pediatric Gastroenterology, Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran.

2 Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran.

Abstract

Background: Pediatric functional constipation is a common issue that imposes significant personal and societal burdens. While managing painful defecation is essential 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 polyethylene glycol (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 defecations per week, and stool consistency as primary outcomes at baseline and after the intervention. 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 numbers needed to treat (NNT) in addition to their 95% confidence interval using MedCalc.
Results: Our study indicates 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.

Keywords

  1. Hussain SZ, Labrum B, Mareya S, Stripling S, Clifford R. Safety of lubiprostone in pediatric patients with functional constipation: a nonrandomized, open-label trial. Journal of Pediatric Gastroenterology and Nutrition. 2021 Nov 1;73(5):572-8.
  2. 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 Journal of Pharmaceutical Sciences. 2012 Dec;20:1-9.
  3. Hartman EE, Pawaskar M, Williams V, McLeod L, Dubois D, Benninga MA, et al. Psychometric properties of PedsQL generic core scales for children with functional constipation in the Netherlands. Journal of pediatric gastroenterology and nutrition. 2014 Dec 1;59(6):739-47.
  4. 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. Frontiers in Neuroscience. 2024 Mar 7;18:1341656.
  5. Sood M, Lichtlen P, Perez MC. Unmet needs in pediatric functional constipation. Clinical Pediatrics. 2018 Nov;57(13):1489-95.
  6. Tran DL, Sintusek P. Functional constipation in children: What physicians should know. World journal of gastroenterology. 2023 Feb 28;29(8):1261.
  7. Mansour HA, Ibrahim A, Mohamed A. Effectiveness of polyethylene glycol 3350 versus lactulose in management of functional constipation in children. Int J Pediatr Res. 2022;8(1):089.
  8. Thompson AP, MacDonald SE, Wine E, Scott SD. Understanding parents’ experiences when caring for a child with functional constipation: interpretive description study. JMIR pediatrics and parenting. 2021 Jan 20;4(1):e24851.
  9. Seth R, Heyman MB. Management of constipation and encopresis in infants and children. Gastroenterology Clinics of North America. 1994 Dec 1;23(4):621-36.
  10. Sharif F, Crushell E, O'driscoll K, Bourke B. Liquid paraffin: a reappraisal of its role in the treatment of constipation. Archives of disease in childhood. 2001 Aug 1;85(2):121-4.
  11. Rafati MR, 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: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences. 2011;19(2):154.
  12. of the North CG. Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition. 2006 Sep;43(3):e1-3.
  13. Rachel H, Griffith AF, Teague WJ, Hutson JM, Gibb S, Goldfeld S, et al. Polyethylene glycol dosing for constipation in children younger than 24 months: a systematic review. Journal of Pediatric Gastroenterology and Nutrition. 2020 Aug 1;71(2):171-5.
  14. MedCalc Statistical Software version 1926 (MedCalc Software bv, Ostend, Belgium; https://wwwmedcalcorg; 2020)" from the text box into your manuscript.
  15. Evaluating the Effect of Adding Paraffin to the Polyethylene Glycol-Senna Combination Therapy for the Treatment of Functional Constipation: Yazd azad university; 1392.
  16. 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. 2023 Jul 21;102(29):e34294.
  17. Aronson JK, editor. Meyler's Side Effects of Drugs (Sixteenth Edition). Oxford: Elsevier; 2016.