Status:
COMPLETED
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
National Center for Research Resources (NCRR)
GlaxoSmithKline
Conditions:
Gastroenteritis
Vomiting
Eligibility:
All Genders
6-10 years
Phase:
NA
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 ...
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 gastroenteri...
Eligibility Criteria
Inclusion
- Acute gastroenteritis
- Non-bilious and non-bloody vomiting within 4 hours of triage
- Diarrhea
- Mild to moderate dehydration
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00120744
Start Date
January 1 2004
End Date
April 1 2005
Last Update
April 17 2018
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