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
Details
Lead Sponsor:
IRCCS Burlo Garofolo
Collaborators:
Agenzia Italiana del Farmaco Mario Negri Institute for Pharmacological Research