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

• Need for intravenous fluid administration
  
• Number and duration of vomiting and diarrhea
  
• Side effects
  
• Revisit rates
  
• Parental absenteeism from work will be compared between the two groups
  

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.