Safety and efficacy of rectal indomethacin for prevention of post‐endoscopic retrograde cholangiopancreatography pancreatitis in pediatric patients

Objectives Peri‐procedural rectal indomethacin was shown to decrease the incidence of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in adults undergoing ERCP. This practice was generalized to pediatric populations, despite an absence of data on safety or efficacy. This study evaluated the safety and efficacy of rectal indomethacin in pediatric patients undergoing ERCP. Methods We conducted a retrospective, cohort study of pediatric patients undergoing ERCP (single‐endoscopist) at two tertiary academic hospitals from November 2009 to August 2024. Safety outcomes included bleeding and acute kidney injury (AKI). The efficacy outcome was incidence of PEP with and without indomethacin at 100 mg > 30 kg and 50 mg < 30 kg. Descriptive statistics, univariate analysis, and binary logistic regression adjusting for 18 covariates were performed. Results A total of 906 ERCPs were performed in 448 patients. Indomethacin was administered in 757 (83.6%) procedures and not in 148 (16.3%). Bleeding occurred in 3.2% versus 3.4% ( p = 0.90), and AKI in 1.1% versus 0.7% ( p = 0.67). PEP incidence was 3.0% with indomethacin versus 9.5% without ( p < 0.05). On multivariate analysis, indomethacin significantly reduced PEP (odds ratio [OR] = 0.28, 95% confidence interval [CI] [0.11–0.71], p < 0.05; absolute risk reductions [ARR] = 6.5%; number needed to treat [NNT] = 16) without increasing bleeding or AKI. Findings were similar in subgroup analysis of index ERCPs with no increased odds of bleeding or AKI and significantly lower odds of PEP (OR = 0.16, 95%CI[0.05–0.53], p < 0.05; ARR = 12.7%; NNT = 8). Conclusions The use of peri‐procedural rectal indomethacin was safe and effective, with no increased bleeding or AKI and a greater than threefold reduction in PEP in pediatric patients. These findings support the use of indomethacin prophylaxis in pediatric patients at 100 mg > 30 kg and 50 mg < 30 kg.