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

NCT ID: NCT00120744

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-04-30

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.

Conditions

Gastroenteritis; Vomiting; Diarrhea; Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Ondansetron Oral Disintegrating Tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stephen Freedman

Adjunct Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen B Freedman, MDCM, MSCI

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Related Links

http://www.nejm.org/doi/full/10.1056/NEJMoa055119

Publication

Other Identifiers

2003-12038

Identifier Type: -

Identifier Source: org_study_id