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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
palonosetron IV 1 mcg/kg
palonosetron 3mcg/kg IV
Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
Moscow, Russia
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Time frame: 0-72 hours post-operatively
Proportion of Patients With Complete Response 0-24 Hours
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Time frame: 0-24 hours
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