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

The Hospital for Sick Children

Status

Completed

Conditions

Vomiting

Dehydration

Diarrhea

Gastroenteritis

Treatments

Drug: Ondansetron Oral Disintegrating Tablet

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00120744

2003-12038

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

6 months to 10 years old

Volunteers

No 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