Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial.

Federico Marchetti,Francesca Rovere,Maurizio Bonati,Andrea Guala,Luca Ronfani,Salvatore Renna,Antonio Clavenna,Egidio Barbi,Paolo Biban,Antonino Reale,Tiziana Zangardi,Liviana Da Dalt,Enrico Valletta,Anna Pazzaglia,Davide Zanon,Alessandra Maestro,Elisa Mazzoni,A Arrighini ,Antonio Urbino ,P Bertolani ,A Vitale ,Paolo Perri

doi:10.1371/journal.pone.0165441

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.

Highlights

Acute gastroenteritis (AGE) is the main cause of acute vomiting in children under the age of 3 years and one of the most important reasons for admission to the pediatric emergency department (ED) and the hospital [1,2]
In the USA, 1.5 million children under 5 years are diagnosed with AGE annually and this condition accounts for 13% of all hospital admissions [1]
Participants were recruited between July 7, 2011 and November 3, 2013

Summary

Introduction

Acute gastroenteritis (AGE) is the main cause of acute vomiting in children under the age of 3 years and one of the most important reasons for admission to the pediatric emergency department (ED) and the hospital [1,2]. Vomiting is a direct cause of fluid loss and can hamper successful treatment with oral rehydration solution (ORS). Symptomatic pharmacological treatment for vomiting is still a matter of debate and is not systematically included in current practice recommendations for pediatric AGE [5,6,7]. Physicians and parents in ED favor intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom [8, 9]. Effective antiemetic treatment would lead to an important reduction in the use of IVT

Methods

Results

Conclusion