Optimization Lumbar Puncture In Children

Beijing Children's Hospital

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Spinal Puncture Complications

Interventions

lidocaineDRUG

surface anesthesia with lidocaine

postoperative managementPROCEDURE

lying without the pillow for half an hour after lumbar puncture

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

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

Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.

Time frame: up to four hours postoperation

degree of adaptability

evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Time frame: intraoperative

time of lumbar puncture

Time frame: intraoperative

number of puncture

Time frame: intraoperative

success rate

Time frame: intraoperative

comfort degree

evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Time frame: up to four hours postoperation

whether bad memories exist or not

A questionaire about the operation for all parents and children will be investigated.

Time frame: up to four hours postoperation

Data from ClinicalTrials.gov

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