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

NCT00124787 | Completed Phase 4

• 1 other identifier: PROJET 2078
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Number of good outcome, defined as 1 episode or less of vomiting 24 hours after the first dose of drug administration.

  24 hours

Secondary Outcomes (5)

• Need for intravenous fluid administration

  24 hours

• Number and duration of vomiting and diarrhea

  7 days

• Side effects

  7 days

• Revisit rates

  7 days

• Parental absenteeism from work will be compared between the two groups

  7 days

Study Arms (2)

Dimenhydrinate

EXPERIMENTAL

dimenhydrinate PO x 4 doses

Drug: Dimenhydrinate

Placebo

PLACEBO COMPARATOR

placebo PO x 4 doses

Drug: Placebo

Interventions

Dimenhydrinate DRUG

Dimenhydrinate PO q 6 hours x 4 doses

Dimenhydrinate

Placebo DRUG

Placebo PO q 6 hours x 4 doses

Placebo

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Canadian Association of Emergency Physicians: collaborator

Study Sites (1)

Ste-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Gastroenteritis

Interventions

Dimenhydrinate

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diphenhydramine; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Serge Gouin, MDCM, FRCPC

  Ste-Justine Hospital, Department of Pediatrics, Montreal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: July 28, 2005
• Study Start: April 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

CA (1)