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.

S2k-Leitlinie „Akute infektiöse Gastroenteritis im Säuglings-, Kindes- und Jugendalter“ – AWMF Registernummer 068-003

“…In einer doppelblinden randomisierten kontrollierten Studie aus Italien wurde die 1-malige orale Gabe von Ondansetron, Domperidon oder Placebo bei Kindern mit einem aufgrund von Erbrechen gescheiterten ersten Rehydrationsversuch verglichen [146]. Eine nachfolgende intravenöse Flüssigkeitstherapie war bei 11,8 % der Patienten in der Ondansetron-und 25,2 % der Domperidonbzw.…”

Gastrointestinal symptoms in children: Primary care and specialist interface

“…This is a selective serotonin receptor blocker that inhibits initiation of the vomiting reflex in the periphery. Recently, it has been demonstrated that ondansetron reduces the risk of intravenous rehydration by over 50%, both with placebo and domperidone . However, a clearance on safety in children is needed before a final recommendation is made, because of a warning regarding possible cardiac effects (such as prolongation of the QT interval) .…”

“…A systematic evaluation of all Cochrane reviews evaluating commonly used interventions in children with vomiting due to acute gastroenteritis by Freedman et al 29 showed significant reduction in hospital admission and intravenous rehydration rates with oral ondansetron use.This is a selective serotonin receptor blocker that inhibits initiation of the vomiting reflex in the periphery. Recently, it has been demonstrated that ondansetron reduces the risk of intravenous rehydration by over 50%, both with placebo and domperidone 30. However, a clearance on safety in children is needed before a final recommendation is made, because of a warning regarding possible cardiac effects (such as prolongation of the QT interval) 31.…”

A importância da partilha da informação clínica: o relato de caso de uma reação adversa

“…Como alternativa à metoclopramida, a administração de fármacos com segurança bem estabelecida, como o ondansetron e a domperidona (apesar de antidopaminérgico, atravessa a barreira hemato-encefálica em reduzidas quantidades, ao contrário da metoclopramida), é aconselhada. 1,5…”