Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department

Study Overview
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Brief Summary
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The objectives of the study were to determine whether ondansetron treatment would reduce: the amount of vomiting in the emergency department; the need for intravenous rehydration; and the need for hospitalization.

Detailed Description
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Background: Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase. Methods: The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.

Official Title
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Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department

Conditions
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Vomiting, Gastroenteritis, Diarrhea, Dehydration

Intervention / Treatment
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* Drug: Ondansetron Oral Disintegrating Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute gastroenteritis Non-bilious and non-bloody vomiting within 4 hours of triage Diarrhea Mild to moderate dehydration Exclusion Criteria: Weight less than 8 kilograms Severe dehydration Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics) History of abdominal surgery Hypersensitivity to the drug or any components in its formulation

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ondansetron Oral Disintegrating Tablet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization. |  |  |