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.