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

Not Applicable

Completed

• Conditions: Gastroenteritis; Vomiting; Diarrhea; Dehydration

• Registration Number: NCT00120744
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-07-12
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-19
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Acute gastroenteritis
• Non-bilious and non-bloody vomiting within 4 hours of triage
• Diarrhea
• Mild to moderate dehydration

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.