Optimization Lumbar Puncture In Children

NCT ID: NCT02454894

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

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.

Conditions

Spinal Puncture Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

no anesthesia; postoperative management

Group Type: EXPERIMENTAL

postoperative management

Intervention Type: PROCEDURE

lying without the pillow for half an hour after lumbar puncture

Group 2

no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 3

surface anesthesia with lidocaine; postoperative management

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

surface anesthesia with lidocaine

postoperative management

Intervention Type: PROCEDURE

lying without the pillow for half an hour after lumbar puncture

Group 4

surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

surface anesthesia with lidocaine

Interventions

lidocaine

surface anesthesia with lidocaine

Intervention Type: DRUG

postoperative management

lying without the pillow for half an hour after lumbar puncture

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Liu

Chief physician/Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Childrens' Hospital

Other Identifiers

20150206

Identifier Type: -

Identifier Source: org_study_id