Triage Administration of Ondansetron for Gastroenteritis in Children

• Status: Terminated
• Trial end date: 2020-10-03
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to assess whether ondansetron given at triage can reduce the number of patients requiring emergency department observation in children with acute gastroenteritis. The investigators will also assess the improvement of patient comfort and total length of stay

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Children aged more than 6 months and weight ≥ 8kg

• At least 4 non-bilious, non-bloody vomiting in the preceding 24 hours

• The last vomiting occured less than 2 hours ago

• No other diagnostic more likely than gastroenteritis suspected by the nurse at triage.

Exclusion Criteria:

• Severe dehydration (based on poor capillary refill or hypotension)

• Underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia)

• Bilious or bloody vomiting

• Bloody stool

• A history of abdominal surgery

• Allergy to ondansetron

• Long QT syndrome or major cardiac condition

• Previous enrolment in the study.

• Girl at risk of pregnancy (pubertal girl)

• Inability to obtain parental informed consent (language barrier, absence, etc.)