Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Phase 3

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: palonosetron

• 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

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Disposition First Submitted: 2010-04-15
• Disposition First Submitted QC: 2010-04-15
• Disposition First Posted: 2010-04-16
• Results First Submitted: 2014-06-27
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-28
• Results First Posted: 2014-08-15
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

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 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

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 Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"; 🇷🇺 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

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

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