A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

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?
    

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 been a limited
      number of clinical trials studying this subject matter and health authorities'
      recommendations are only based on expert opinion. Surveys have shown that despite this lack
      of evidence, physicians do quite frequently prescribe these drugs. Dimenhydrinate, a
      histamine receptor blocker, has been proven safe and effective in controlling post-operative
      nausea and vomiting in children. To our knowledge, no clinical trial has been conducted to
      study its efficacy in children with acute gastroenteritis.

      Objective: To evaluate the efficacy and safety of oral dimenhydrinate in the treatment of
      vomiting due to acute gastroenteritis in children.

      Design: Randomized, double-blind, placebo controlled clinical trial.

      Setting: Emergency Department (ED) of an urban pediatric university-affiliated center.

      Study population: Children from 1 to 12 years of age presenting to the ED with at least 5
      episodes of vomiting in the previous 12 hours and diagnosed with acute gastroenteritis by
      attending physicians.

      Interventions: Study participants will be randomly allocated to receive 8 doses of
      dimenhydrinate or placebo every six hours (1mg/kg/dose, max dose 50mg/dose)

      Primary outcome measure: Number of good outcome, defined as 1 episode or less of vomiting 24
      hours after the first dose of drug administration.

      Secondary outcome measures: Need for intravenous fluid administration, number and duration of
      vomiting and diarrhea, side effects, revisit rates and parental absenteeism from work will be
      compared between the two groups

      Sample size and statistics: Based on previously reported data, the researchers estimate that
      approximately 70% of patients will be free of emesis in the initial 24 hours post medication
      first dose. The researchers would like to obtain a good outcome in more than 85% with the
      active medication. With an alpha error of 0.05 and a power of 90%, approximately 90 patients
      per group will be needed. Patients' characteristics and outcomes will be compared using the
      Mann Whitney U test and the Chi-square test for categorical variables and the Student's T
      test for continuous variables. Survival curves will also be analyzed.
    

Intervention name(s): Dimenhydrinate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dimenhydrinate PO q 6 hours x 4 doses; Placebo PO q 6 hours x 4 doses
Intervention MeSH terms: Dimenhydrinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment