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Efficacy and Safety of Polyethylene Glycol versus Placebo in Pediatric Foreign-body Ingestion: A Randomized Pilot
Veerabhadra Radhakrishna1, Nitin Kumar1, Raghunath Bangalore Vasudeva1
1Department of Pediatric Surgery, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India.
Insights
This pilot study found polyethylene glycol (PEG) safe and feasible for children with foreign body ingestion (FBI). PEG may speed up foreign body passage, especially in older children.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trials
Background:
- Foreign body ingestion (FBI) is a common pediatric issue, often requiring intervention.
- Current evidence for laxative use in pediatric FBI is limited.
- This study piloted a randomized controlled trial (RCT) for polyethylene glycol (PEG) in pediatric FBI.
Purpose of the Study:
- To evaluate the feasibility of a larger RCT assessing PEG versus placebo in pediatric FBI.
- To assess recruitment, retention, adherence, acceptability, and tolerability of PEG in pediatric FBI.
- To generate hypotheses regarding PEG's efficacy on foreign body transit time.
Main Methods:
- A pilot randomized controlled trial (RCT) involving children aged 1-18 years with FBI.
- Participants received either PEG (1 g/kg/day) or an aspartame placebo until foreign body passage or for 7 days.
- Feasibility outcomes and foreign-body transit time were primary and secondary endpoints, respectively.
Main Results:
- The study demonstrated 100% retention and 96% adherence, with high acceptability and satisfaction.
- No adverse events were reported, indicating safety.
- Mean foreign-body transit time was significantly shorter with PEG (55.8 h) compared to placebo (86.8 h), particularly in children over 10 years.
Conclusions:
- A randomized trial of PEG for pediatric FBI is feasible, safe, and well-accepted.
- Preliminary results suggest PEG may accelerate foreign body transit, especially in older children.
- These findings support the rationale for a larger, powered RCT to confirm PEG's efficacy.
Background:
Foreign body ingestion (FBI) is common in children, with 10%-20% requiring endoscopic intervention and 1% requiring surgery. Despite its frequency, evidence supporting the use of laxatives in FBI is scarce, limited to case reports, case series, and expert opinions. This pilot randomized controlled trial (RCT) evaluated the feasibility of a larger RCT assessing polyethylene glycol (PEG) versus placebo in pediatric FBI.
Methods:
Children aged 1-18 years with the FBI were randomized to receive PEG (1 g/kg/day) or aspartame placebo (8 mg/kg/day) until foreign body passage or a maximum of 7 days. Feasibility outcomes included recruitment, retention, adherence, acceptability, and tolerability. The primary efficacy outcome (hypothesis-generating) was foreign-body transit time.
Results:
Among 69 children (71 FBIs), retention was 100%, and adherence was 96%. The acceptability and satisfaction scores were high (4.9/5 and 4.7/5, respectively). No adverse events were reported. The mean FB transit time was shorter in the PEG group than in the placebo (55.8 ± 39.3 vs. 86.8 ± 66.9 h; P = 0.032; Cohen's d ≈ 0.54). The reduction in FB transit time appeared more pronounced in children >10 years (53.7 ± 12.7 vs. 112.8 ± 45.3 h; P < 0.001; Cohen's d ≈ 1.77).
Conclusion:
A randomized trial of PEG in pediatric FBI is feasible, well accepted, and safe. Preliminary findings suggest PEG may enhance foreign body transit, particularly in older children, supporting the rationale for a larger, adequately powered RCT.
