A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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 in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis.

RESEARCH QUESTION

Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Justine's Hospital
• Collaborator: Canadian Association of Emergency Physicians
• Treatments: Dimenhydrinate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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