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

Post-Operative Nausea and Vomiting Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Nausea
  • Post-Operative Nausea and Vomiting
  • Postoperative Nausea and Vomiting
  • Vomiting
Clinical Trial Details
NCT number NCT00231478
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 4
Start date April 2007
Completion date December 2007
View Details
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