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.

Condition	Intervention
Gastroenteritis Vomiting Diarrhea Dehydration	Drug: Ondansetron Oral Disintegrating Tablet

Further Study Details: 

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

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.

Ages Eligible for Study:  6 Months   -   10 Years,  Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Stephen B Freedman, MDCM, MSCI,  Principal Investigator,  The Hospital for Sick Children   

Study ID Numbers:  2003-12038
Last Updated:  July 25, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120744
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02