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Comparison of Polyethylene Glycol 3350+Electrolytes vs. Polyethylene Glycol 4000 for Fecal Disimpaction in Pediatric
Kalpana Panda1, J Bikrant Kumar Prusty2, Mrutunjay Dash2
1Division of Pediatric Gastroenterology and Hepatology, Department of Pediatric, Institute of Medical Sciences and SUM Hospital, Bhubaneswar, Odisha, India.
Insights
Polyethylene glycol (PEG) 3350+electrolyte and PEG 4000 are equally effective for pediatric fecal disimpaction. PEG 4000 offers better taste, with both formulations well-tolerated by children.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trials
Background:
- Polyethylene glycol (PEG) is a first-line treatment for pediatric functional constipation and fecal impaction.
- Commonly available PEG formulations include PEG 3350+electrolyte (E) and PEG 4000.
- Hypothesized benefits include reduced electrolyte imbalance risk for PEG 3350+E and improved palatability for PEG 4000.
Purpose of the Study:
- To compare the efficacy, tolerability, and acceptability of PEG 3350+E versus PEG 4000 for fecal disimpaction in children.
- To address the lack of head-to-head comparisons between these two PEG formulations for this indication.
Main Methods:
- A double-blind, randomized controlled trial (RCT) included pediatric patients diagnosed with functional constipation and fecal impaction (ROME IV criteria).
- Exclusion criteria included organic constipation, prior gastrointestinal surgery, and current PEG or lactulose use.
- Patients received either PEG 3350+E or PEG 4000 at 1.5 gm/kg/day for up to 6 days or until impaction resolution.
Main Results:
- Efficacy was similar between PEG 3350+E (84%) and PEG 4000 (86%) (p=0.9).
- Adverse event rates did not significantly differ between the groups; abdominal discomfort and vomiting were most common.
- PEG 4000 demonstrated significantly better palatability (p=0.044), though compliance rates were similar.
Conclusions:
- PEG 3350+E and PEG 4000 exhibit comparable efficacy in pediatric fecal disimpaction with similar safety profiles.
- PEG 4000 is preferred due to superior palatability, and both formulations are well-tolerated in children.
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.
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