Background: Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is\nalso a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in\nthe emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration\nwhen vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an\nimportant reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of\nhospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most\nrecently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical\npractice, such as domperidone, is lacking.\nObjectives: To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting\nin children with AG who have failed ORT.\nMethods/Design: Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children\naged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration\nwill be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to\nreceive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight);\n3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic\noral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study\noutcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made\n48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled.\nDiscussion: The trial results would provide evidence on the efficacy of domperidone, which is largely used in\nclinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to\nondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The\ntrial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children\nwith AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate\ntransferability of results.\nTrial Registration: ClinicalTrials.gov: NCT01257672
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