Dimenhydrinate in children with infectious gastroenteritis: a prospective, RCT.
OBJECTIVE
Vomiting is a common symptom in children with infectious gastroenteritis. It contributes to fluid loss and is a limiting factor for oral rehydration therapy. Dimenhydrinate has traditionally been used for children with gastroenteritis in countries such as Canada and Germany. We investigated the efficacy and safety of dimenhydrinate in children with acute gastroenteritis.


METHODS
We performed a prospective, randomized, placebo-controlled, multicenter trial. We randomly assigned 243 children with presumed gastroenteritis and vomiting to rectal dimenhydrinate or placebo. Children with no or mild dehydration were included. All children received oral rehydration therapy. Primary outcome was defined as weight gain within 18 to 24 hours after randomization. Secondary outcomes were number of vomiting episodes, fluid intake, parents' assessment of well-being, number of diarrheal episodes, and admission rate to hospital. We recorded potential adverse effects.


RESULTS
Change of weight did not differ between children who received dimenhydrinate or placebo. The mean number of vomiting episodes between randomization and follow-up visit was 0.64 in the dimenhydrinate group and 1.36 in the placebo group. In total, 69.6% of the children in the dimenhydrinate group versus 47.4% in the placebo group were free of vomiting between randomization and the follow-up visit. Hospital admission rate, fluid intake, general well-being of the children, and potential adverse effects, including the number of diarrhea episodes, were similar in both groups.


CONCLUSIONS
Dimenhydrinate reduces the frequency of vomiting in children with mild dehydration; however, the overall benefit is low, because it does not improve oral rehydration and clinical outcome.
Uhlig
Ulrike
U
Section of Pediatric Gastroenterology, University Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany. holm.uhlig@medizin.unileipzig.de
Pfeil
Nicole
N
Gelbrich
Götz
G
Spranger
Christian
C
Syrbe
Steffen
S
Huegle
Boris
B
Teichmann
Barbara
B
Kapellen
Thomas
T
Houben
Peggy
P
Kiess
Wieland
W
Uhlig
Hans Holm
HH
D000208:Acute Disease; D000932:Antiemetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D003681:Dehydration / Q000209:etiology / Q000517:prevention & control; D004111:Dimenhydrinate / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005440:Fluid Therapy; D005500:Follow-Up Studies; D005759:Gastroenteritis / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007223:Infant; D008297:Male; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013488:Suppositories; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy* / Q000209:etiology
D000932:Antiemetics; D013488:Suppositories; D004111:Dimenhydrinate