ORAL ONDANSETRON VS DOMPERIDONE FOR SYMPTOMATIC TREATMENT OF VOMITING DURING ACUTE GASTROENTERITIS IN CHILDREN: MULTICENTRE RANDOMIZED CONTROLLED TRIAL - SYMPTOMATIC TREATMENT OF ACUTE GASTROENTERITIS

Active, not recruiting

Conditions: Acute gastroenteritis
MedDRA version: 9.1Level: LLTClassification code 10066762

Registration Number: EUCTR2010-019787-36-IT

Lead Sponsor: ISTITUTO PER L`INFANZIA BURLO GAROFOLO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) age from 1 to 6 years; 2) presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea; 3) more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED; 2) underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease); 3) severe dehydration: weight loss>10% or standardized clinical dehydration score >=18 for children aged 12-24 months and >=16 for older children(20); 4) known hypersensitivity to ondansetron or domperidone; 5) previous enrolment in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether the oral administration of a symptomatic drug (ondansetron or domperidone) prevents intravenous or nasogastric rehydration in children vomiting and diagnosed acute gastroenteritis.;Secondary Objective: To assess whether the oral administration of a symptomatic drug (ondansetron or domperidone) reduces the total duration and the number of vomiting episodes and the need for hospital admission or ED access.;Primary end point(s): Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of Oral Rehydration Solution.

Secondary Outcome Measures