Anesthesia Lumbar Puncture In Children (ALPIC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- degree of adaptability
研究概览
简要总结
The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
详细描述
The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with indications of lumbar puncture;
- •voluntarily signed the informed consent
排除标准
- •topical anesthetic skin allergies;
- •skin infection in lumbar puncture site;
- •severe intracranial hypertension;
- •unstable vital signs;
- •coagulopathy;
- •intracranial hemorrhage and occupying;
- •low back pain;
- •headache and low back pain before lumbar puncture;
- •past headache after lumbar puncture;
- •mental retardation, neuropsychiatric symptoms;
- •children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);
- •the case with repeated puncture in one operation
研究组 & 干预措施
Group 1
surface anesthesia with lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
degree of adaptability
时间窗: intraoperative
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
次要结局
- time of lumbar puncture(intraoperative)
- number of puncture(intraoperative)
- success rate(intraoperative)
- whether bad memories exist or not(up to four hours postoperation)
研究者
Gang Liu
Chief physician/Professor
Beijing Children's Hospital