At a glance
ClinicalIndex Comparison Record- ✓Age 2–16 years
- ✓Scheduled elective tonsillectomy or adenotonsillectomy requiring general anesthesia and endotracheal intubation
- ✓Hospital admission for no longer than 24 hours
- ✕Known allergy or contraindication to granisetron (Kytril) or its components
- ✕Known allergy to any other 5HT3 antagonist
- ✕History of motion sickness or post-operative nausea and vomiting
- ✕Nausea or vomiting in the 24 hours prior to anesthesia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating granisetron for Post-Operative Nausea and Vomiting. Completed, enrolled 171 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
20 micrograms intravenously (iv) 15 min prior to end of surgery
40 micrograms intravenously (iv) 15 min prior to end of surgery