Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting palonosetron pediatric
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

Detailed description:

Arms:
arm 1: Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) arm 2: Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

Interventions: intervention 1: palonosetron intervention 2: palonosetron
Intervention descriptions: intervention 1: palonosetron IV 1 mcg/kg intervention 2: palonosetron 3mcg/kg IV

Protocol document: