Efficacy and Safety of Polyethylene Glycol versus Placebo in Pediatric Foreign-body Ingestion: A Randomized Pilot Trial

A BSTRACT 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.