Optimization Lumbar Puncture In Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization Lumbar Puncture In Children

Conditions
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Spinal Puncture Complications

Intervention / Treatment
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* Drug: lidocaine
* Procedure: postoperative management


Participation Criteria
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Eligibility Criteria
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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; 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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>no anesthesia; postoperative management | Procedure: postoperative management<br>* lying without the pillow for half an hour after lumbar puncture<br>|
| No Intervention: Group 2<br>no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture | |
| Experimental: Group 3<br>surface anesthesia with lidocaine; postoperative management | Drug: lidocaine<br>* surface anesthesia with lidocaine<br>Procedure: postoperative management<br>* lying without the pillow for half an hour after lumbar puncture<br>|
| Experimental: Group 4<br>surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture | Drug: lidocaine<br>* surface anesthesia with lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy |  | up to five days postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration. |  | up to four hours postoperation | 
| degree of adaptability | evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale | intraoperative | 
| time of lumbar puncture |  | intraoperative | 
| number of puncture |  | intraoperative | 
| success rate |  | intraoperative | 
| comfort degree | evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale | up to four hours postoperation | 
| whether bad memories exist or not | A questionaire about the operation for all parents and children will be investigated. | up to four hours postoperation |