Back to resultsSafety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
palonosetron
palonosetron
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, palonosetron, pediatric
Eligibility Criteria
MAIN INCLUSION CRITERIA
- Male or female patient aged more than 28 days (full term) up to and including 16 years.
Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:
- ear, nose and throat surgery;
- eye surgery;
- orchidopexy;
- plastic reconstructive surgery;
- herniorraphy;
- orthopedic surgery).
- American Society of Anesthesiologists (ASA) physical status I, II or III.
- Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
- Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
- For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.
MAIN EXCLUSION CRITERIA
- For infant aged more than 12 months: a history of gastro-esophageal reflux.
- For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
- Patient scheduled to undergo emergency surgery.
- Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
- Patient scheduled to receive propofol during the maintenance phase of anesthesia.
- Patient with vomiting from any organic cause.
- Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
- Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Sites / Locations
- Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
- Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
- Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
- State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
- State Healthcare Institution 'Regional Pediatric Clinical Hospital'
- Cherkassy Regional Hospital, Pediatric Surgery Department
- Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
- M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
- Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
- Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
- 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
- Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
- Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 mcg/kg arm
3 mcg/kg arm
Arm Description
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
Outcomes
Primary Outcome Measures
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Secondary Outcome Measures
Proportion of Patients With Complete Response 0-24 Hours
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00828295
Brief Title
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Official Title
A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting, palonosetron, pediatric
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 mcg/kg arm
Arm Type
Experimental
Arm Description
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Arm Title
3 mcg/kg arm
Arm Type
Experimental
Arm Description
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
Intervention Type
Drug
Intervention Name(s)
palonosetron
Intervention Description
palonosetron IV 1 mcg/kg
Intervention Type
Drug
Intervention Name(s)
palonosetron
Intervention Description
palonosetron 3mcg/kg IV
Primary Outcome Measure Information:
Title
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
Time Frame
0-72 hours post-operatively
Secondary Outcome Measure Information:
Title
Proportion of Patients With Complete Response 0-24 Hours
Description
Complete Response defined as no vomiting, no retching, and no use of rescue medication
Time Frame
0-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
MAIN INCLUSION CRITERIA
Male or female patient aged more than 28 days (full term) up to and including 16 years.
Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:
ear, nose and throat surgery;
eye surgery;
orchidopexy;
plastic reconstructive surgery;
herniorraphy;
orthopedic surgery).
American Society of Anesthesiologists (ASA) physical status I, II or III.
Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.
MAIN EXCLUSION CRITERIA
For infant aged more than 12 months: a history of gastro-esophageal reflux.
For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
Patient scheduled to undergo emergency surgery.
Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
Patient scheduled to receive propofol during the maintenance phase of anesthesia.
Patient with vomiting from any organic cause.
Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
Facility Information:
Facility Name
Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
City
Moscow
Country
Russian Federation
Facility Name
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
City
Moscow
Country
Russian Federation
Facility Name
Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
City
St. Petersburg
Country
Russian Federation
Facility Name
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
City
St. Petersburg
Country
Russian Federation
Facility Name
State Healthcare Institution 'Regional Pediatric Clinical Hospital'
City
Yaroslavl
Country
Russian Federation
Facility Name
Cherkassy Regional Hospital, Pediatric Surgery Department
City
Cherkassy
Country
Ukraine
Facility Name
Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
City
Dnipropetrovsk
Country
Ukraine
Facility Name
M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
City
Donetsk
Country
Ukraine
Facility Name
Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
City
Kyiv
Country
Ukraine
Facility Name
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
City
Kyiv
Country
Ukraine
Facility Name
Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
City
Kyiv
Country
Ukraine
Facility Name
Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
City
Lviv
Country
Ukraine
12. IPD Sharing Statement
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Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
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