Oral ondansetron versus domperidone for acute gastroenteritis in pediatric emergency departments: Multicenter double blind randomized controlled trial

Federico Marchetti, M. Bonati, Alessandra Maestro, Davide Zanon, Francesca Rovere, A. Arrighini, Egidio Barbi, Paolo Bertolani, Paolo Biban, Liviana Da Dalt, Andrea Guala, Elisa Mazzoni, Anna Pazzaglia, Paolo Francesco Perri, Antonino Reale, Salvatore Renna, Antonio Urbino, E. Valletta, A. Vitale, T. ZangardiAntonio Clavenna, Luca Ronfani, Alessia Fratte, Alessandra Knowles, Marta Massaro, Gianni Messi, Rossella Paparazzo, Elisa Zanelli, Chiara Donati, Annamaria Sorlini, Linda Balanzoni, Davide Silvagni, Paola Berlese, Mariaelena Cavicchiolo, Paola Angellotti, Luigina Boscardini, A. Lambertini, Chiara Landini, Francesco Mannelli, Simona Montano, Roberta Piccinini, Luciana Maria Taccari, Francesca Faa, Laura Bergamino, Pasquale Di Pietro, Francesca Bosetti, Emanuele Castagno, Martina Fornaro, B. Mainetti, Maria Grazia Scalone, Giovanna Roberta Vega, Susanna Masiero, Stefania Scanferla

Research output: Contribution to journalArticlepeer-review


The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1-6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20-0.83) and domperidone (RR 0.47, 98.6% CI 0.23-0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1-6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.

Original languageEnglish
Article numbere0165441
JournalPLoS One
Issue number11
Publication statusPublished - Nov 1 2016

ASJC Scopus subject areas

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)


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