Optimization Lumbar Puncture In Children

Not Applicable

Withdrawn

• Conditions: Spinal Puncture Complications
• Interventions: Procedure: postoperative management; Drug: lidocaine

• Registration Number: NCT02454894
• Lead Sponsor: Beijing Children's Hospital

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.

Study Timeline

• Study First Submitted: 2015-03-13
• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1	postoperative management	no anesthesia; postoperative management
Group 3	postoperative management	surface anesthesia with lidocaine; postoperative management
Group 3	lidocaine	surface anesthesia with lidocaine; postoperative management
Group 4	lidocaine	surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture

Primary Outcome Measures

Name	Time	Method
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy	up to five days postoperation

Secondary Outcome Measures

Name	Time	Method
time of lumbar puncture	intraoperative
degree of adaptability	intraoperative	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
comfort degree	up to four hours postoperation	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
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	A questionaire about the operation for all parents and children will be investigated.