Status:
COMPLETED
A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Canadian Association of Emergency Physicians
Conditions:
Gastroenteritis
Eligibility:
All Genders
1-12 years
Phase:
PHASE4
Brief Summary
Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich ...
Detailed Description
STRUCTURED RESEARCH ABSTRACT Background: The use of antiemetic drugs to treat nausea and vomiting during an episode of acute gastroenteritis in children remains controversial. To date, there have bee...
Eligibility Criteria
Inclusion
- Children aged from 1 to 12 years old with more than 5 episodes of vomiting in the 12 hours preceding their diagnosis of acute gastroenteritis by an ED attending physician
Exclusion
- Pre-existing chronic medical condition such as gastro-intestinal disease, malignancy, metabolic, cardiac, endocrine, immunologic or neurologic disorder
- Suspected secondary diagnosis of surgical abdomen or gynecologic condition, urinary tract infection, migraine or meningitis
- Use of antiemetic therapy within 48 hours prior to ED visit
- Use of medication other than acetaminophen or ibuprofen in the previous 48 hours
- History of allergy or adverse reaction to dimenhydrinate
- Severe dehydration requiring immediate intravenous fluid therapy
- Hematemesis or hematochezia
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00124787
Start Date
April 1 2005
End Date
February 1 2012
Last Update
March 1 2012
Active Locations (1)
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1
Ste-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5