Management Following Lumbar Puncture In Children (MFLPIC)

Capital Medical University

Status: Unknown

Conditions: Spinal Puncture Complications

Treatments: Procedure: optimized postoperative management

Study type: Interventional

Funder types: Other

Identifiers

NCT02590718

20150826

Details and patient eligibility

About

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 (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire about bad memory during lumbar puncture 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 comfortable LP will be established upon completion of this study.

Enrollment: 200 estimated patients

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: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group 1

Experimental group

Description:

optimized postoperative management(lying without the pillow for half an hour after lumbar puncture)

Treatment:

Procedure: optimized postoperative management

Group 2

No Intervention group

Description:

traditional postoperative management(lying without the pillow and fasting water and food for four hours after lumbar puncture)