NCT02174874

Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 462 (actual)
• Sponsor: Dr. Graham Thompson · Academic / Other
• Sex: All
• Age: 3 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.

Detailed description

Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.

Conditions

• Acute Gastroenteritis

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-05-01
• Completion: 2014-06-01
• First posted: 2014-06-26
• Last updated: 2014-06-26

Locations

1 site across 1 country: Canada