Symptomatic Treatment of Acute Gastroenteritis

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Vomiting in children with acute gastroenteritis is a major factor of failure of oral rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important reduction in the use of Intravenous Fluid Therapy. 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.

The aim of this multicentre, double-blind randomized controlled trial is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with acute gastroenteritis who have failed Oral Rehydration Therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Burlo Garofolo
• Collaborators: Agenzia Italiana del Farmaco; Mario Negri Institute for Pharmacological Research
• Treatments: Domperidone; Ondansetron

Criteria

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;

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;

4. known hypersensitivity to ondansetron or domperidone;

5. previous enrolment in the study.