DOSE-AGE Study

Multi-dose Ondansetron for Pediatric Acute Gastroenteritis: A Pragmatic Randomized Controlled Trial

Study Summary

Gastroenteritis results in millions of visits to Emergency Departments (EDs) and over 450,000 hospitalizations each year in North America. There are limited treatment options available to children presenting with vomiting secondary to gastroenteritis. To encourage oral rehydration therapy, clinicians will administer ondansetron, an anti-emetic (anti-vomiting) medication. Increasingly, clinicians are sending children home with multiple doses of ondansetron however there is little evidence to suggest this is beneficial and it comes at an increased cost to the family and healthcare system.

DOSE-AGE is a randomized, placebo controlled, double blind clinical trial assessing multiple doses of oral ondansetron, compared with placebo, in children with vomiting secondary to acute gastroenteritis. 1030 children, ages 6 months to 18 years will be enrolled in the study from six Canadian institutions. Participants are randomized to receive multiple (6) doses of oral ondansetron or a matching placebo which can be administered to the child in the 48 hours after their ED visit on an as needed basis, as determined by their caregiver at home.

Objectives

  1. 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 following their ED visit significantly different in those who take ondansetron  at home compared to those who receive a placebo
  2. To investigate among the children receiving ondansetron, is there a difference in the:
    - duration​​​​​​ and frequency of vomiting?
    - proportion of children who require unscheduled health visits after their ED visit?
    - proportion of children who require Intravenous (IV) rehydration?
    - caregiver satisfaction with the at-home therapy provided?
  3. To determine if the discharge of children with gastroenteritis associated vomiting who are administered ondansetron in the ED with additional doses to be taken at home is associated with adverse events (e.g. increased diarrhea)

Principal Study Investigator: Dr. Stephen Freedman

Project Lead: Sarah Williamson-Urquhart

Study Team: Dr. Andrew Dixon, Dr. Darcy Beer, Dr. Amy Plint, Dr. Serge Gouin, Dr. Gary Joubert, Dr. Terry Klassen, Dr. Anna Heath, Dr. Chris McCabe, Dr. Yaron Finkelstein, Petros Pechlivanoglou, Erin Kirwin, David Rios