Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
- Registration Number
- NCT00828295
- Lead Sponsor
- Helsinn Healthcare SA
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mcg/kg arm palonosetron Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) 3 mcg/kg arm palonosetron Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
- Primary Outcome Measures
Name Time Method Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively 0-72 hours post-operatively
- Secondary Outcome Measures
Name Time Method Proportion of Patients With Complete Response 0-24 Hours 0-24 hours Complete Response defined as no vomiting, no retching, and no use of rescue medication
Trial Locations
- Locations (13)
Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
🇷🇺St. Petersburg, Russian Federation
State Healthcare Institution 'Regional Pediatric Clinical Hospital'
🇷🇺Yaroslavl, Russian Federation
Cherkassy Regional Hospital, Pediatric Surgery Department
🇺🇦Cherkassy, Ukraine
Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
🇺🇦Dnipropetrovsk, Ukraine
Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department
🇺🇦Kyiv, Ukraine
Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
🇺🇦Kyiv, Ukraine
Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
🇺🇦Lviv, Ukraine
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, Russian Federation
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
🇷🇺Moscow, Russian Federation
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
🇷🇺St. Petersburg, Russian Federation
M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
🇺🇦Donetsk, Ukraine
Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
🇺🇦Ivano-Frankivsk, Ukraine
Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
🇺🇦Kyiv, Ukraine