Optimization Lumbar Puncture In Children (OLPIC)

Capital Medical University

Status: Withdrawn

Conditions: Spinal Puncture Complications

Treatments: Drug: lidocaine; Procedure: postoperative management

Study type: Interventional

Funder types: Other

Identifiers

NCT02454894

20150206

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Group 1

Experimental group

Description:

no anesthesia; postoperative management

Treatment:

Procedure: postoperative management

Group 2

No Intervention group

Description:

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

Group 3

Experimental group

Description:

surface anesthesia with lidocaine; postoperative management

Treatment:

Drug: lidocaine

Procedure: postoperative management

Group 4

Experimental group

Description:

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

Treatment:

Drug: lidocaine