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临床试验/NCT00214370
NCT00214370已完成不适用

Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension

研究概览

简要总结

The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better sedation induction, recovery profile and is preferred by patients/families. The study is a double blind, randomized, placebo controlled crossover study. Following the induction phase of chemotherapy, children will be randomized in a crossover manner to receive either fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied on two separate occasions, once with propofol-placebo (normal saline) and once with propofol-fentanyl. Children will be monitored continuously by pulse oximetry, electrocardiogram (ECG) and direct nursing and physician observation during the sedation in accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7 for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be recorded every 3 minutes by a study investigator during sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • Children ages 2 years to 18 years with acute leukemia/lymphoma cared for by physicians in the Division of Hematology/Oncology in the Department of Pediatrics and receiving sedation for diagnostic/therapeutic lumbar punctures (LPs) in the UW Pediatric Sedation Program
  • Enrollment will occur after the induction phase of chemotherapy.

排除标准

  • American Society of Anesthesiology score ≥ 3
  • Cardiorespiratory instability
  • Allergy to propofol or its components
  • Age less than 2 years
  • Patients receiving other sedative analgesics
  • Patients with an oxygen requirement

结局指标

主要结局

Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension

次要结局

  • Patient/family preference, ease of induction, and recovery pattern

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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