NCT00231478

A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy

A Randomized, Double-blind Study of 2 Dose Levels of Kytril on the Prevention of Post-operative Nausea and Vomiting in Pediatric Patients Undergoing Surgery With General Anesthesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.

Conditions

• Post-Operative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	granisetron	20 micrograms intravenously (iv) 15 min prior to end of surgery
DRUG	granisetron	40 micrograms intravenously (iv) 15 min prior to end of surgery

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-10-04
• Last updated: 2018-03-27
• Results posted: 2011-04-28

Locations

11 sites across 1 country: United States