drugset / Trial / NCT01395901
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-03
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ondansetron | Other / unclassified | 0.1 mg/kg | Intravenous |
| Comparator | Ondansetron | Other / unclassified | 4 mg | Intravenous |
| Subject | Palonosetron | Other / unclassified | 1 ug/kg | Intravenous |
Indications
No indication recorded.