Effect of Intravenous Pantoprazole on Clinical Outcomes in Pediatric Acute Gastroenteritis: A Placebo-Controlled RCT

Vollständiger Abstract

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Objective: Acute gastroenteritis (AGE) is a common cause of pediatric emergency visits, and vomiting often complicates oral rehydration. Despite lack of evidence, proton pump inhibitors (PPIs) are sometimes used empirically for persistent vomiting. We evaluated the effect of intravenous pantoprazole on clinical outcomes in children with AGE and persistent vomiting after ondansetron. Methods: This double-blind, placebo-controlled randomized trial was conducted at Bahrami Children’s Hospital, Tehran, Iran Children aged 4 months to 18 years with AGE and persistent vomiting despite ondansetron were randomized to receive intravenous pantoprazole (2 mg/kg/d) or placebo. Primary outcomes were vomiting frequency, time to oral tolerance, and length of hospital stay. Analyses used the Mann-Whitney U test, the Fisher exact test, and the ordinal logistic regression. Results: Of 100 children [51 pantoprazole, 49 placebo; median age 14 months (IQR: 11 to 24), 67% male], there were no significant differences between groups in post-treatment vomiting episodes ( P =0.64), time to oral tolerance at 6 hours (71% vs. 79%, P =0.37) or 12 hours (86% vs. 86%, P =0.78). However, hospital length of stay was significantly longer in the pantoprazole group [median 2 days (IQR: 1 to 3) vs. 1 day (IQR: 1 to 2), P =0.01]. Ordinal logistic regression showed that the placebo group had 80% lower odds of prolonged hospitalization (adjusted OR=0.2, 95% CI: 0.09-0.43). Subgroup analyses revealed that this difference was more pronounced in children under 2 years, regardless of reflux history, and in formula-fed children ( P =0.01 for each). Conclusions: Intravenous pantoprazole does not reduce vomiting or improve oral tolerance in children with acute gastroenteritis. Furthermore, it is associated with longer hospital stays. Empirical PPI use in this setting is not supported by current evidence.