Management Following Lumbar Puncture In Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.
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 (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire 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 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
结局指标
主要结局
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.
时间窗: up to five days postoperation
次要结局
- comfort degree(up to four hours postoperation)
- whether bad memories exist or not(up to four hours postoperation)
- Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.(up to four hours postoperation)
研究者
Gang Liu
Chief physician/Professor
Beijing Children's Hospital