oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children multicentre randomized controlled trial口服联合与domperidone期间呕吐的症状治疗儿童急性胃肠炎的多中心随机对照试验.pdf

Marchetti et al. BMC Pediatrics 2011, 11:15 /1471-2431/11/15 STUDY PROTOCOL Open Access 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†, Luca Ronfani1† 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 vo