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临床试验/NCT00553839
NCT00553839已完成不适用

Pharmacokinetics of Ketamine in Infants and Children

Stanford University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Total Clearance and Intercompartmental Clearance

研究概览

简要总结

Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers.

详细描述

This is an open label study that will be conducted in infants and children presenting for procedures (eg., surgery or cardiac catheterization) at Stanford and Lucile Packard Children's hospital in California and at The Children's Hospital in Denver, CO. Patients with abnormal kidney or liver functions will be excluded from the study as the dysfunction in these organs affects the clearance of medications from the body and affects dosing. Preterm neonates will also be excluded. All patients will be premedicated and anesthetised at the discretion of the anesthesia faculty providing clinical care for the child. Once the patient's procedure is underway, a 0.5 cc blood sample will be drawn from an intravenous line. This is the preload blood sample (T0). Following this a 2mg/kg intravenous bolus of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). Five minutes after the bolus, timed blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. (Total 14 blood samples; total blood required is 7 mls for the entire study). When the procedure is completed the anesthesiologist will awaken the patient as per their usual practice. Blood samples that still need drawing will be done in the post-anesthesia recovery room or intensive care or ward-any location where the patient is likely to remain after the surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Term infants (38 weeks gestation)and infants and children up to age 18 years.
  • Patients who require procedures that necessitate at least 8 hours in the hospital and those being admitted after procedure will be eligible to participate.
  • Patients who will receive ketamine as part of their standard anesthesia regimen.

排除标准

  • Preterm neonates
  • Liver Disease
  • Kidney disease
  • Heart failure
  • Patients receiving anticonvulsants or barbiturates

研究组 & 干预措施

Ketamine

Other

Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure

干预措施: ketamine hydrochloride (Drug)

结局指标

主要结局

Total Clearance and Intercompartmental Clearance

时间窗: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model.

Central and Peripheral Volume of Distribution

时间窗: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Central and Peripheral Volume of Distribution were analyzed using Bootstrap model.

Residual Error

时间窗: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Residual Error was analyzed using Bootstrap model.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chandra Ramamoorthy

Professor of Anesthesia

Stanford University

研究点 (2)

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