Management Following Lumbar Puncture In Children

Not Applicable

• Conditions: Spinal Puncture Complications
• Interventions: Procedure: optimized postoperative management

• Registration Number: NCT02590718
• 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 (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.

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
comfort degree	up to four hours postoperation	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
whether bad memories exist or not	up to four hours postoperation	A questionaire about the operation for all parents and children will be investigated.
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.	up to four hours postoperation