Oral ondansetron versus domperidone for symptomatic treatment of vomiting during
acute gastroenteritis in children: multicentre randomized controlled trial.
Author(s): Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da
Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F,
Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A,
Bonati M, Ronfani L.
Affiliation(s): Department of Pediatrics and Epidemiology and Biostatistics Unit, Institute for
Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy.
Publication date & source: 2011, BMC Pediatr. , 11:15
BACKGROUND: Vomiting in children with acute gastroenteritis (AG) is not only a
direct cause of fluid loss but it is also a major factor of failure of oral
rehydration therapy (ORT). Physicians who provide care to paediatric patients in
the emergency department (ED) usually prescribe intravenous fluid therapy (IVT)
for mild or moderate dehydration when vomiting is the major symptom. Thus,
effective symptomatic treatment of vomiting would lead to an important reduction
in the use of IVT and, consequently, of the duration of hospital stay and of
frequency of hospital admission. Available evidence on symptomatic treatment of
vomiting shows the efficacy of the most recently registered molecule
(ondansetron) but a proper evaluation of antiemetics drugs largely used in
clinical practice, such as domperidone, is lacking.
OBJECTIVES: To compare the efficacy of ondansetron and domperidone for the
symptomatic treatment of vomiting in children with AG who have failed ORT.
METHODS/DESIGN: Multicentre, double-blind randomized controlled trial conducted
in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a
presumptive clinical diagnosis of AG, and without severe dehydration will be
included. After the failure of a initial ORS administration in ED, eligible
children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body
weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main
study outcome will be the percentage of patients needing nasogastric or IVT after
symptomatic oral treatment failure, defined as vomiting or fluid refusal after a
second attempt of ORT. Data relative to study outcomes will be collected at 30
minute intervals for a minimum of 6 hours. A telephone follow up call will be
made 48 hours after discharge. A total number of 540 children (i.e. 180 patients
in each arm) will be enrolled.
DISCUSSION: The trial results would provide evidence on the efficacy of
domperidone, which is largely used in clinical practice despite the lack of
proper evaluation and a controversial safety profile, as compared to ondansetron,
which is not yet authorized in Italy despite evidence supporting its efficacy in
treating vomiting. The trial results would contribute to a reduction in the use
of IVT and, consequently, in hospital admissions in children with AG. The design
of this RCT, which closely reflect current clinical practice in EDs, will allow
immediate transferability of results.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT01257672.