Multi-dose Oral Ondansetron for Pedatric Gastroenteritis: A Randomized Controlled Trial
OVERVIEW
Status: Recruiting Complete
ClinicalTrials.Gov Identifier: NCT03851835
Principal Investigator: Dr. Stephen Freedman
Project Manager: Angela Wallace
POPULATION
Children and youth, age 6 months to 17.99 years will be enrolled at six (6) Canadian Emergency Departments. The total number of participants recruited will be 1030.
OBJECTIVES
Primary Objective:
To determine if in previously healthy children, who present to an ED with gastroenteritis associated vomiting, is the proportion who develop moderate to severe disease [Modified Vesikari Score (MVS) ≥ 9] following ED evaluation, significantly different in those who receive ondansetron at home compared to those who receive placebo.
Secondary Objectives
In this group of patients, amongst those receiving active treatment versus placebo:
Is there a difference in the (a) duration of vomiting, (b) frequency of vomiting, or (c) the proportion who experience vomiting following ED disposition?
Is there a difference in the proportion who require an unscheduled health care provider visit?
Is there a difference in the proportion who require intravenous rehydration?
Is there a difference in the caregiver satisfaction with the therapy provided?