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. 2025 Jul;28(4):233-244.
doi: 10.5223/pghn.2025.28.4.233. Epub 2025 Jul 7.

Comparison of Polyethylene Glycol 3350+Electrolytes vs. Polyethylene Glycol 4000 for Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial

Kalpana Panda  1 , J Bikrant Kumar Prusty  2 , Mrutunjay Dash  2 , Basudev Biswal  2 , Mamata Devi Mohanty  2 , Prasant Kumar Saboth  2
Affiliations

Comparison of Polyethylene Glycol 3350+Electrolytes vs. Polyethylene Glycol 4000 for Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial

Kalpana Panda et al. Pediatr Gastroenterol Hepatol Nutr. 2025 Jul.

Abstract

Purpose: Polyethylene glycol (PEG) is recommended as the first-line laxative for fecal disimpaction in pediatric functional constipation. PEG 3350+electrolyte (E) and PEG 4000 are the most commonly available formulations. PEG 3350+E and PEG 4000 have hypothesized benefits of lower risk of electrolyte imbalance and better palatability, respectively. However, a head-to-head comparison of these two formulations for fecal disimpaction remains lacking. This study aimed to compare the efficacy, tolerability, and acceptability of PEG 3350+E vs. PEG 4000 for fecal disimpaction in pediatric functional constipation.

Methods: This double-blind, randomized controlled intention-to-treat trial included pediatric patients with functional constipation (as per ROME IV) and fecal impaction. Patients with organic constipation, h/o prior to gastrointestinal surgery, and those who were already receiving PEG/lactulose were excluded. Computer-generated block randomization was performed. Colorless liquid formulations of study medication were provided by investigator (JBK) as per treatment allocation in identical opaque bottles @1.5 gm/kg/dayx6 days or until fecal impaction resolution (passage of clear liquid stool), whichever is earlier.

Results: One hundred patients were randomized in a 1:1 ratio (50 patients in each arm). Efficacy of PEG 3350+E vs. PEG 4000 was similar (84% vs. 86%; p=0.9). Similarly, no significant differences were noted in the adverse event rates between two groups. Abdominal discomfort and vomiting were the most common adverse effects. PEG 4000 showed better palatability than PEG 3350+E (p=0.044). However, there was no significant difference in the compliance rate.

Conclusion: PEG 3350+E and PEG 4000 showed similar efficacies for fecal disimpaction, with minor side effects. PEG 4000 had better palatability; however, both were well tolerated by children.

Keywords: Constipation; Fecal impaction; Pediatrics; Polyethylene glycols.

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Conflict of interest statement

Conflict of Interest: The authors have no financial conflicts of interest.

Figures

Fig. 1
Fig. 1. Consort diagram for the randomized controlled trial.
PEG: polyethylene glycol.
Fig. 2
Fig. 2. Comparison between PEG 3350+ electrolytes and PEG 4000 for fecal disimpaction in pediatric functional constipation with respect to (A) efficacy (% of participants with successful fecal disimpaction); (B) adverse effects; (C) palatability.
PEG: polyethylene glycol.
See this image and copyright information in PMC

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