跳至主要内容
临床试验/NCT01099462
NCT01099462Unknown不适用

Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年6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
入组人数
30
试验地点
1
主要终点
Ibuprofen concentration in the CSF

研究概览

简要总结

Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 3 month-18 years
  • Rectal temperature > 38.0OC or oral temperature > 37.6 OC measured in the ED or at home.
  • A sepsis work up is indicated
  • At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture (LP)

排除标准

  • Hypersensitivity to Ibuprofen
  • Known metabolic disorder
  • Known liver or kidney disease
  • Hydrocephalus
  • Informed consent could not be obtained from a legal guardian

研究组 & 干预措施

Children with fever

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Ibuprofen concentration in the CSF

时间窗: 30 - 360 minutes after administration

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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