Conditions: Postoperative Nausea and Vomiting
Keywords: Prevention of Postoperative Nausea and Vomiting Palonosetron Ondansetron Pediatric
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 670
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Intervention: Drug: Palonosetron arm 2: Intervention: Drug: Comparator: Ondansetron

Interventions: intervention 1: Palonosetron intervention 2: Ondansetron intervention 3: Placebo to Ondansetron intervention 4: Placebo to Palonosetron
Intervention descriptions: intervention 1: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) intervention 2: Single dose Ondansetron IV:

* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg intervention 3: None intervention 4: None

Protocol document: