Intramuscular Versus Oral Ondansetron for Management of Children with Acute Dehydrating Diarrhea and Vomiting: A Randomized Controlled Trial
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Date
2025-06
Journal Title
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Publisher
Indian Academy of Pediatrics
Abstract
OBJECTIVES To compare efficacy and safety of intramuscular (IM) ondansetron with oral ondansetron for improving u?liza?on of Oral Rehydra?on Therapy (ORT) by controlling vomi?ng in children with acute diarrhea and some dehydra?on. METHODS We enrolled children aged 3 months to 12 years presen?ng with acute diarrhea (dura?on < 14 days) with some dehydra?on, and at least two episodes of vomi?ng within last 6 h in an open-label randomized controlled trial. Par?cipants were randomized to receive single dose (0.2 mg/kg) of IM or oral ondansetron before star?ng ORT. Primary outcome was failure of ORT (persistence of some dehydra?on a?er 4 h of ORT or need for intravenous fluids). Secondary outcomes included need for unscheduled intravenous fluids, amount of Oral Rehydra?on Salt Solu?on (ORS) ingested a?er 4 h, frequency of vomi?ng episodes, adverse effects, and caregiver sa?sfac?on. RESULTS We randomized 60 children (31 IM, 29 oral); 58 (29 per group) were followed-up for all outcomes. There were no significant differences between IM and oral routes in terms of ORT failure (31% vs. 24.1%; RR (95% CI) 1.3 (0.5, 3.0), P = 0.557), need for IV fluids during ORT (24.1% vs. 20.7%; P = 0.753), mean (SD) ORS ingested (mL) in 4 h [616.2 (429.7) vs. 645.5 (403.5); P = 0.79], mean (SD) frequency of vomi?ng [1.4 (2.0) vs. 2.3 (2.4); P = 0.107] or caregiver sa?sfac?on. No adverse events a?ributable to the interven?on were observed. CONCLUSION Intramuscular ondansetron may not off er any advantage over oral use in management of children with acute diarrhea with vomi?ng and some dehydra?on.
Description
Keywords
Acute gastroenteritis, Oral rehydration therapy, Some dehydration, Treatment failure
Citation
Satyesh Shubham, Meena Rajesh Kumar, Shah Dheeraj, Saha Rumpa, Gupta Piyush . Intramuscular Versus Oral Ondansetron for Management of Children with Acute Dehydrating Diarrhea and Vomiting: A Randomized Controlled Trial. Indian Pediatrics. 2025 Jun; 62(6): 414-420