Anesthesia Lumbar Puncture In Children

Study Overview
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Brief Summary
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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.

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) and comfortable LP will be established upon completion of this study.

Official Title
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Anesthesia Lumbar Puncture In Children (ALPIC)

Conditions
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Spinal Puncture, Anesthesia

Intervention / Treatment
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* Drug: Lidocaine


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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>surface anesthesia with lidocaine | Drug: Lidocaine<br>* surface anesthesia with lidocaine<br>|
| No Intervention: Group 2<br>no anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of adaptability | evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of lumbar puncture |  | intraoperative | 
| number of puncture |  | intraoperative | 
| success rate |  | intraoperative | 
| whether bad memories exist or not | A questionaire about the operation for all parents and children will be investigated. | up to four hours postoperation |