Effect of Intravenous Pantoprazole on Clinical Outcomes in Pediatric Acute Gastroenteritis: A Placebo-Controlled RCT.
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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