1Pediatria, Ospedale di Ravenna, AUSL della Romagna; 2IRCCS Materno-Infantile “Burlo Garofolo”, Trieste; 3Istituto di Ricerche Farmacologiche "Mario Negri", Milano; 4Pediatria, AO Spedali Civili, Brescia; 5Pediatria, Università di Modena e Reggio Emilia; 6Pediatria, Azienda Ospedaliera Universitaria, Verona; 7Pediatria, Ospedale di Treviso; 8Pediatria, Ospedale di Verbania; 9Pediatria, Ospedale Maggiore, Bologna; 10Ospedale “A. Meyer”, Firenze; 11Pediatria, Ospedale di Macerata; 12IRCCS “Bambino Gesù”, Roma; 13Istituto “G. Gaslini”, Genova; 14Pediatria, Ospedale “Regina Margherita”, Torino; 15Pediatria, Ospedale di Forlì, AUSL della Romagna; 16Pediatria, Ospedale di Avellino; 17Pediatria, Università di Padova
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Key words: Acute gastroenteritis, Ondansetron, Domperidone, Oral rehydration, Intravenous rehydration
Background - Vomiting limits the success of oral rehydration in children with acute gastroenteritis (AGE). A double-blind randomized trial was conducted to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AGE who have failed oral rehydration.
Methods - After failure of initial oral rehydration administration, children aged 1-6 years admitted for gastroenteritis to the paediatric emergency units 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.
Results - 1313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization: 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.
Conclusions - 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 effective- ly with the administration of oral rehydration solution alone. In children who fail oral rehydration, a single dose of oral ondansetron reduces vomiting and facilitates oral rehydration and may thus be well suited for use in the emergency department. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.
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