Anesthesia Lumbar Puncture In Children

Not Applicable

• Conditions: Spinal Puncture; Anesthesia
• Interventions: Drug: Lidocaine

• Registration Number: NCT02590705
• Lead Sponsor: Beijing Children's Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Last Update Submitted: 2015-10-28
• Study First Posted: 2015-10-29
• Last Update Posted: 2015-10-29
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	Lidocaine	surface anesthesia with lidocaine

Primary Outcome Measures

Name	Time	Method
degree of adaptability	intraoperative	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Secondary Outcome Measures

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