Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroenteritis; Vomiting; Diarrhea; Dehydration
Intervention: Ondansetron Oral Disintegrating Tablet (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Stephen B Freedman, MDCM, MSCI, Principal Investigator, Affiliation: The Hospital for Sick Children
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.
Clinical Details
Official title: Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring 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.
Eligibility
Minimum age: 6 Months.
Maximum age: 10 Years.
Gender(s): 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
Locations and Contacts
Additional Information
Starting date: January 2004
Ending date: April 2005
Last updated: September 7, 2006
|
