Published online September 14, 2009
PEDIATRICS Vol. 124 No. 4 October 2009, pp. e622-e632 (doi:10.1542/peds.2008-1650)

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ARTICLE

Dimenhydrinate in Children With Infectious Gastroenteritis: A Prospective, RCT

Ulrike Uhlig, MD^a,b, Nicole Pfeil, MD(sci)^a,c, Götz Gelbrich, PhD^c, Christian Spranger, MD^a,c, Steffen Syrbe, MD^a, Boris Huegle, MD^a, Barbara Teichmann, MD^d, Thomas Kapellen, MD^a,c, Peggy Houben, PhD^c, Wieland Kiess, MD^a and Hans Holm Uhlig, MD, DPhil^a

^a Section of Pediatric Gastroenterology, University Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany
^b Section of Pediatric Gastroenterology, University Hospital for Children and Adolescents, Martin Luther University Halle, Halle, Germany
^c Coordination Centre for Clinical Studies Leipzig, Leipzig, Germany
^d Private Pediatric Practice, Leipzig, Germany

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.

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Key Words: gastroenteritis • vomiting • dimenhydrinate • children • randomized • controlled trial

Abbreviations: CI—confidence interval • NNT—number needed to treat

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Accepted Jun 1, 2009.

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