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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
670
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
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
Proportion of Patients With Complete Response
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Time frame: 0-24 hours after T0
Proportion of Patients With no Vomiting
Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Time frame: 0-24 hours after T0
Proportion of Patients Without Emetic Episodes
An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Time frame: 0-24 hours after T0
Proportion of Patients Without Antiemetic Rescue Medication
Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
Time frame: 0-24 hours after T0
Proportion of Patients Without Nausea (Patient Aged > 6 Years)
Time frame: 0-24 hours after T0
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