Open Access Highly Accessed Study protocol

Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

Federico Marchetti1*, Alessandra Maestro2†, Francesca Rovere2†, Davide Zanon2†, Alberto Arrighini3†, Paolo Bertolani4†, Paolo Biban5†, Liviana Da Dalt6†, Pasquale Di Pietro7†, Salvatore Renna7†, Andrea Guala8†, Francesco Mannelli9†, Anna Pazzaglia9†, Gianni Messi10†, Francesco Perri11†, Antonino Reale12†, Antonio Francesco Urbino13†, Enrico Valletta14†, Antonio Vitale15†, Tiziana Zangardi16†, Maria Teresa Tondelli17†, Antonio Clavenna18†, Maurizio Bonati18† and Luca Ronfani1†

Author Affiliations

1 Department of Pediatrics and Epidemiology and Biostatistics Unit, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy

2 Clinical Services of Pharmacy, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy

3 Pediatric Emergency Department, P.O. Spedali Civili, Brescia, Italy

4 Department of Pediatrics, Azienda Policlinico, Modena, Italy

5 Pediatric Intensive Care Unit, Ospedale Civile Maggiore, Verona, Italy

6 Department of Pediatrics, Ospedale di Treviso, Treviso, Italy

7 Emergency Room and Emergency Medicine Division, G. Gaslini Institute, Genova, Italy

8 Department of Pediatrics, Ospedale Castelli, Verbania, Italy

9 Emergency Department, Paediatric Hospital A. Meyer, Firenze, Italy

10 Emergency Department, Institute for Maternal and Child Health - IRCCS Burlo Garofolo, Trieste, Italy

11 Department of Pediatrics, Ospedale di Macerata, Macerata, Italy

12 Emergency Department, Ospedale Pediatrico Bambino Gesú, IRCCS, Roma, Italy

13 Emergency Department, Ospedale Infantile Regina Margherita di Torino, Torino, Italy

14 Department of Pediatrics, Ospedale GB Morgagni, Forlì, Italy

15 Pediatric Emergency Department, Ospedale Giuseppe Moscati, Avellino, Italy

16 Pediatric Emergency Department, Azienda Ospedaliera - University of Padova, Padova, Italy

17 Department of Pediatrics, Azienda Ospedaliera, University of Parma, Italy

18 Maternal and Child Health Laboratory, Institute Mario Negri, Milano, Italy

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BMC Pediatrics 2011, 11:15 doi:10.1186/1471-2431-11-15

Published: 10 February 2011

Abstract

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