title: Oral dimenhydrinate versus placebo in children with gastroenteritis: a randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral dimenhydrinate in the treatment of acute gastroenteritis.
  
  
  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.
  
  
  RESULTS
  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. The proportions of adverse effects were similar in both groups (53% vs 54%).
  
  
  CONCLUSIONS
  The prescription of oral dimenhydrinate did not significantly decrease the frequency of vomiting in children with acute gastroenteritis compared with placebo.
authors.affiliation: Division of Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada. sergegouin@aol.com
authors.forename: Serge
authors.initials: S
authors.lastname: Gouin
authors.forename: Thuy-Tien
authors.initials: TT
authors.lastname: Vo
authors.forename: Michel
authors.initials: M
authors.lastname: Roy
authors.forename: Denis
authors.initials: D
authors.lastname: Lebel
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Gravel
mesh_terms: D000284:Administration, Oral; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004111:Dimenhydrinate / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005759:Gastroenteritis / Q000188:drug therapy* / Q000453:epidemiology; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007223:Infant; D008297:Male; D012894:Sleep Stages / Q000187:drug effects / Q000502:physiology; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D000932:Antiemetics; D004111:Dimenhydrinate