Multi-dose Oral Ondansetron for Pedatric Gastroenteritis: A Randomized Controlled Ttial
Principal Investigator: Stephen Freedman
Project Manager: Sarah Williamson-Urquhart
Sponsor: The University of Calgary
A phase III, double-blind, parallel-design, randomized, placebo controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.
The primary outcome will be the post-index visit Modified Vesikari Scale (MVS) score.
Primary Endpoint: Post-index visit MVS score. Secondary Endpoints will include:
1. Vomiting: Frequency, Duration, Proportion (i.e. yes/no)
2. Health care use: Emergency Department, Primary Care
3. Intravenous rehydration
4. Caregiver Satisfaction with Therapy Provided: Likert Scale
Description of Study Intervention
Children who are provided a minimum of one dose of ondansetron as part of their routine clinical care AND meet other eligibility criteria will be randomized to receive an at-home kit with six (6) doses of Ondansetron Hydrochloride Dihydrate Oral Solution (4mg/5mL solution; dosed at 0.15mg/kg to a maximum single dose of 8mg) or equivalent volume in a Placebo Oral Solution to be administered no sooner than 8 hours after the initial clinical dose was provided by the ED physician. Over the subsequent 48 hours, the study intervention will be administered at a rate of 1 dose every 8 hours (q8h) to a maximum of 3 doses a day (in a 24 hour period (TID)) at the caregiver’s discretion. Two (2) additional doses will be provided to the caregiver in case the child vomits a dose.
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:
1. Is there a difference in the (a) duration of vomiting, (b) frequency of vomiting, or (c) the proportion who experience vomiting following ED disposition?
2. Is there a difference in the proportion who require an unscheduled health care provider visit?
3. Is there a difference in the proportion who require intravenous rehydration?
4. Is there a difference in the caregiver satisfaction with the therapy provided?
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.
Description of Sites/Facilities Enrolling Participants
Participants will be enrolled at six pediatric emergency departments across Canada: Alberta Children’s Hospital (Calgary, AB), Centre Hospitalier Universitaire de Sainte Justine (Montréal, QC), Children’s Hospital of Eastern Ontario (Ottawa, ON), London Health Sciences Centre – Children’s Hospital (London, ON), Stollery Children’s Hospital (Edmonton, AB), and the Health Sciences Centre – Children’s Hospital (Winnipeg, MB)
Approximately 36 months of active recruiting will be required to meet the sample size of 1030.
Screening, consent, and randomization will take place at the initial ED (baseline) visit. The follow-up period will last 7 days with questionnaires issued 24 hours, 48 hours and 168 hours (7 days) after informed consent is received, by telephone or email.