drugset / Trial / NCT00231478
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2007-12
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Granisetron | Other / unclassified | 20 ug | Intravenous |
| Subject | Granisetron | Other / unclassified | 40 ug | Intravenous |
Indications
No indication recorded.