Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
2013年6月4日 更新者：Anne M. Lynn、Seattle Children's Hospital
Infants handle ketorolac differently than adults.
Study of handling of this pain medication given to infants following surgery.
Detailed analysis of how the drug is eliminated from age 2 months to 18 months.
Compared morphine use in infants who received the drug to the group getting placebo.
Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.
研究概览
地位
完全的
详细说明
Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months.
Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug.
Morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants.
A modified infant pain scale was used to assure consistent pain management.
研究类型
介入性
注册 (实际的)
77
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
-
-
Washington
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Seattle、Washington、美国、98105
- Seattle Children's 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
2个月 至 1年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months
Exclusion Criteria:
- Bleeding history in infant or family
- Coagulopathy
- Gastrointestinal bleeding history
- Renal or hepatic disease assessed by history and by pre-drug blood tests
- Premature birth (<36 weeks gestation)
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ketorolac 1 mg/kg
ketorolac 1 mg/kg iv given by 10 min infusion
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Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion.
Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
其他名称：
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有源比较器：ketorolac 0.5 mg/kg
ketorolac 0.5 mg/kg iv given by 10 min infusion
|
Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion.
Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
其他名称：
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假比较器：placebo
placebo group received D5W 10 min infusion
|
Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion.
Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery
大体时间：24 hours following surgery
|
stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)
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24 hours following surgery
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Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
大体时间：24 hours after surgery
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stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants
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24 hours after surgery
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Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
大体时间：24 hours post surgery
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peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)
|
24 hours post surgery
|
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Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants
大体时间：24 hours after surgery
|
half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery
|
24 hours after surgery
|
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Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants
大体时间：24 hours after surgery
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stereo-specific ketorolac clearance by population-based analysis (NONMEM)
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24 hours after surgery
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Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants
大体时间：24 hours after surgery
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population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery
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24 hours after surgery
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Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants
大体时间：24 hours after surgery
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population-based analysis of ketorolac stereo-isomers
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24 hours after surgery
|
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Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery
大体时间：24 hours after surgery
|
noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants
|
24 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery
大体时间：first day after surgery
|
total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo
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first day after surgery
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Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants
大体时间：12 hours after ketorolac or placebo infusion
|
continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo
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12 hours after ketorolac or placebo infusion
|
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Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery
大体时间：24 hours after surgery
|
total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery
|
24 hours after surgery
|
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Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants
大体时间：24 hours after surgery
|
continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery
|
24 hours after surgery
|
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。
调查人员
- 首席研究员：Anne M. Lynn, MD、Seattle Children's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.
- Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.
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
2000年5月1日
初级完成 (实际的)
2008年3月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2010年12月9日
首先提交符合 QC 标准的
2010年12月14日
首次发布 (估计)
2010年12月15日
研究记录更新
最后更新发布 (估计)
2013年6月13日
上次提交的符合 QC 标准的更新
2013年6月4日
最后验证
2013年6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.