Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
2015年3月17日 更新者：Helsinn Healthcare SA
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
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.
研究概览
研究类型
介入性
注册 (实际的)
150
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cherkassy、乌克兰
- Cherkassy Regional Hospital, Pediatric Surgery Department
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Dnipropetrovsk、乌克兰
- Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
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Donetsk、乌克兰
- M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
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Ivano-Frankivsk、乌克兰
- Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
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Kyiv、乌克兰
- Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
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Kyiv、乌克兰
- 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
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Kyiv、乌克兰
- Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
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Lviv、乌克兰
- Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
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Moscow、俄罗斯联邦
- Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
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Moscow、俄罗斯联邦
- Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
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St. Petersburg、俄罗斯联邦
- Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
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St. Petersburg、俄罗斯联邦
- State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
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Yaroslavl、俄罗斯联邦
- State Healthcare Institution 'Regional Pediatric Clinical Hospital'
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4周 至 16年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：1 mcg/kg arm
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
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palonosetron IV 1 mcg/kg
palonosetron 3mcg/kg IV
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实验性的：3 mcg/kg arm
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
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palonosetron IV 1 mcg/kg
palonosetron 3mcg/kg IV
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
大体时间：0-72 hours post-operatively
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0-72 hours post-operatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Patients With Complete Response 0-24 Hours
大体时间：0-24 hours
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Complete Response defined as no vomiting, no retching, and no use of rescue medication
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0-24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年8月1日
初级完成 (实际的)
2008年12月1日
研究完成 (实际的)
2009年1月1日
研究注册日期
首次提交
2009年1月22日
首先提交符合 QC 标准的
2009年1月22日
首次发布 (估计)
2009年1月23日
研究记录更新
最后更新发布 (估计)
2015年4月3日
上次提交的符合 QC 标准的更新
2015年3月17日
最后验证
2014年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.