Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis: A Randomized Controlled Trial
Gouin S et al. – The prescription of oral dimenhydrinate did not significantly decrease the frequency of vomiting in children with acute gastroenteritis compared with placebo.Methods
- This was a randomized, double-blind, placebo-controlled trial conducted in the emergency department of a pediatric university-affiliated center.
- Children 1 to 12 years old who presented to the emergency department with at least 5 episodes of vomiting in the previous 12 hours and diagnosed with acute gastroenteritis were block-randomized to receive oral dimenhydrinate (1 mg/kg; maximum: 50 mg) every 6 hours for 4 doses or placebo for 4 doses.
- The primary outcome measure was treatment failure as defined by the occurrence of 2 episodes of vomiting in the 24 hours after administration of the first dose of the study medication.
- During the study period, 209 patients met inclusion criteria, but 50 refused to participate and 7 were missed.
- Eight participants were lost to follow-up, and 144 were thus included in the primary analysis.
- Of these patients, 74 were randomized to receive dimenhydrinate and 70 placebo.
- The proportions of patients showing failure of treatment were similar for both treatment groups: dimenhydrinate, 31% (23 of 74); placebo, 29% (20 of 70) (difference: 0.02 [95% confidence interval: –0.12 to 0.17]). There were no differences between the 2 groups in rates of intravenous cathether insertion, mean number of episodes of vomiting or diarrhea, abdominal pain, nausea, duration of symptoms, revisit rates, or parental absenteeism.