Optimization Lumbar Puncture In Children
Overview
- Phase
- Not Applicable
- Intervention
- postoperative management
- Conditions
- Spinal Puncture Complications
- Sponsor
- Beijing Children's Hospital
- Primary Endpoint
- Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
Detailed Description
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),less postoperative complications and comfortable LP will be anticipated.
Investigators
Gang Liu
Chief physician/Professor
Beijing Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •children with indications of lumbar puncture;
- •voluntarily signed the informed consent
Exclusion Criteria
- •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;
Arms & Interventions
Group 1
no anesthesia; postoperative management
Intervention: postoperative management
Group 3
surface anesthesia with lidocaine; postoperative management
Intervention: lidocaine
Group 3
surface anesthesia with lidocaine; postoperative management
Intervention: postoperative management
Group 4
surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture
Intervention: lidocaine
Outcomes
Primary Outcomes
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy
Time Frame: up to five days postoperation
Secondary Outcomes
- time of lumbar puncture(intraoperative)
- degree of adaptability(intraoperative)
- comfort degree(up to four hours postoperation)
- Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.(up to four hours postoperation)
- number of puncture(intraoperative)
- success rate(intraoperative)
- whether bad memories exist or not(up to four hours postoperation)