Conditions: Post-Operative Nausea and Vomiting
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 171
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: granisetron intervention 2: granisetron
Intervention descriptions: intervention 1: 20 micrograms intravenously (iv) 15 min prior to end of surgery intervention 2: 40 micrograms intravenously (iv) 15 min prior to end of surgery

Protocol document: