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Intramuscular Versus Oral Ondansetron for Management of Children with Acute Dehydrating Diarrhea and Vomiting: A
Shubham Satyesh1, Rajesh Kumar Meena1, Dheeraj Shah2,3
1Department of Pediatrics, University College of Medical Sciences (University of Delhi) and Associated Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, 110095, India.
Insights
Intramuscular ondansetron showed no significant benefit over oral ondansetron in managing vomiting associated with acute diarrhea and dehydration in children. Both methods were equally effective and safe for improving oral rehydration therapy utilization.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Acute diarrhea with vomiting is a common pediatric illness.
- Controlling vomiting is crucial for successful Oral Rehydration Therapy (ORT).
- Ondansetron is an effective antiemetic, but route of administration in this context requires evaluation.
Purpose of the Study:
- To compare the efficacy and safety of intramuscular (IM) ondansetron versus oral ondansetron.
- To assess the impact of ondansetron administration route on Oral Rehydration Therapy (ORT) utilization in children.
- To evaluate ondansetron's effectiveness in controlling vomiting during acute diarrhea and dehydration management.
Main Methods:
- An open-label randomized controlled trial was conducted with children aged 3 months to 12 years.
- Participants presented with acute diarrhea, some dehydration, and at least two vomiting episodes in 6 hours.
- Children received a single dose of either IM or oral ondansetron (0.2 mg/kg) before initiating ORT.
Main Results:
- No significant differences were observed between IM and oral ondansetron groups regarding ORT failure rates (31% vs. 24.1%).
- Both groups showed comparable outcomes in need for intravenous fluids, ORS intake, vomiting frequency, and caregiver satisfaction.
- No adverse events were reported for either administration route.
Conclusions:
- Intramuscular ondansetron does not appear to offer advantages over oral ondansetron for children with acute diarrhea, vomiting, and some dehydration.
- Oral ondansetron is a viable and effective alternative for managing vomiting to facilitate ORT in pediatric patients.
- The study supports the use of oral ondansetron as a safe and effective option in this clinical scenario.
Objectives:
To compare efficacy and safety of intramuscular (IM) ondansetron with oral ondansetron for improving utilization of Oral Rehydration Therapy (ORT) by controlling vomiting in children with acute diarrhea and some dehydration.
Methods:
We enrolled children aged 3 months to 12 years presenting with acute diarrhea (duration < 14 days) with some dehydration, and at least two episodes of vomiting within last 6 h in an open-label randomized controlled trial. Participants were randomized to receive single dose (0.2 mg/kg) of IM or oral ondansetron before starting ORT. Primary outcome was failure of ORT (persistence of some dehydration after 4 h of ORT or need for intravenous fluids). Secondary outcomes included need for unscheduled intravenous fluids, amount of Oral Rehydration Salt Solution (ORS) ingested after 4 h, frequency of vomiting episodes, adverse effects, and caregiver satisfaction.
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 vomiting [1.4 (2.0) vs. 2.3 (2.4); P = 0.107] or caregiver satisfaction. No adverse events attributable to the intervention were observed.
Conclusion:
Intramuscular ondansetron may not offer any advantage over oral use in management of children with acute diarrhea with vomiting and some dehydration.
Trial Registration:
Clinical Trials Registry-India (CTRI/2020/01/023082) available at ctri.nic.in.
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