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

NCT00124787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-03-01

No results posted yet for this study

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?

Conditions

Interventions

DRUG

Dimenhydrinate

Dimenhydrinate PO q 6 hours x 4 doses

DRUG

Placebo

Placebo PO q 6 hours x 4 doses

Sponsors & Collaborators

  • Canadian Association of Emergency Physicians

    collaborator INDUSTRY

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Serge Gouin, MDCM, FRCPC · Ste-Justine Hospital, Department of Pediatrics, Montreal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124787 on ClinicalTrials.gov