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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00120744

Collaborator

National Center for Research Resources (NCRR) (NIH), GlaxoSmithKline (Industry), Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroenteritis Vomiting Diarrhea Dehydration	Drug: Ondansetron Oral Disintegrating Tablet	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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