title: Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial.
abstract: 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.
authors.affiliation: Department of Pediatrics, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Marchetti
authors.affiliation: Laboratory for Mother and Child Health, Department of Public Health, IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonati
authors.affiliation: Pharmacy and Clinical Pharmacology, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Maestro
authors.affiliation: Pharmacy and Clinical Pharmacology, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Zanon
authors.affiliation: Pharmacy and Clinical Pharmacology, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Rovere
authors.affiliation: Pediatric Emergency Department, Presidio Ospedale dei Bambini, A.O. Spedali Civili, Brescia, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Arrighini
authors.affiliation: Pediatric Emergency Department, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Egidio
authors.initials: E
authors.lastname: Barbi
authors.affiliation: Pediatric Unit, Department of Medical and Surgical Sciences for Mothers, Children and Adults, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bertolani
authors.affiliation: Pediatric Emergency Department, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Biban
authors.affiliation: Department of Pediatrics, Treviso Hospital, Treviso, Italy.
authors.forename: Liviana
authors.initials: L
authors.lastname: Da Dalt
authors.affiliation: Department of Pediatrics, Ospedale Castelli, Verbania, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Guala
authors.affiliation: Department of Pediatrics, Ospedale Maggiore, Bologna, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Mazzoni
authors.affiliation: Emergency Department, Pediatric Hospital A. Meyer, Firenze, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Pazzaglia
authors.affiliation: Department of Pediatrics, Ospedale di Macerata, Macerata, Italy.
authors.forename: Paolo Francesco
authors.initials: PF
authors.lastname: Perri
authors.affiliation: Emergency Department, Ospedale Pediatrico Bambino Gesù, IRCCS, Roma, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Reale
authors.affiliation: Emergency Room and Emergency Medicine Division, G. Gaslini Institute, Genova, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Renna
authors.affiliation: Emergency Department, Ospedale Infantile Regina Margherita, Torino, Italy.
authors.forename: Antonio Francesco
authors.initials: AF
authors.lastname: Urbino
authors.affiliation: Department of Pediatrics, Ospedale G.B. Morgagni - L. Pierantoni, Forlì, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Valletta
authors.affiliation: Department of Pediatrics and Pediatric Emergency, "San Giuseppe Moscati" National Hospital (AORN), Avellino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Vitale
authors.affiliation: Pediatric Emergency Department, Azienda Ospedaliera - University of Padova, Padova, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Zangardi
authors.affiliation: Laboratory for Mother and Child Health, Department of Public Health, IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Clavenna
authors.affiliation: Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy.
authors.forename: Luca
authors.identifier: http://orcid.org/0000-0001-5710-3914
authors.initials: L
authors.lastname: Ronfani
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000932:Antiemetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004294:Domperidone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004632:Emergency Medical Services; D004636:Emergency Service, Hospital; D005260:Female; D005759:Gastroenteritis / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D017294:Ondansetron / Q000627:therapeutic use*; D015990:Placebo Effect; D011446:Prospective Studies; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology
chemical_list: D000932:Antiemetics; D017294:Ondansetron; D004294:Domperidone