Status:
WITHDRAWN
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
Lead Sponsor:
Children's Hospitals and Clinics of Minnesota
Conditions:
Dehydration
Gastroenteritis
Eligibility:
All Genders
6-5 years
Phase:
NA
Brief Summary
Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therap...
Eligibility Criteria
Inclusion
- Age 6 months - 5 years
- Clinical diagnosis of acute gastroenteritis
- Mild or moderate dehydration as determined by validated clinical scale
- Clinical assessment to begin IV fluids
- Vomiting ≥ 2 episodes in past 4 hours
Exclusion
- Severe dehydration
- History of significant gastrointestinal, metabolic, renal or cardiac disorder
- Ondansetron allergy
- Non-English language proficient parent/guardian
- Parent/guardian has no telephone
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00691275
Start Date
September 1 2008
End Date
September 1 2009
Last Update
July 14 2015
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