Clinical trial NCT02454894: Optimization Lumbar Puncture In Children
Official title: Optimization Lumbar Puncture In Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Puncture Complications
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy
timeFrame: up to five days postoperation
Secondary outcomes:
measure: Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.
timeFrame: up to four hours postoperation
measure: degree of adaptability
timeFrame: intraoperative
measure: time of lumbar puncture
timeFrame: intraoperative
measure: number of puncture
timeFrame: intraoperative
measure: success rate
timeFrame: intraoperative
measure: comfort degree
timeFrame: up to four hours postoperation
measure: whether bad memories exist or not
timeFrame: up to four hours postoperation
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Childrens' Hospital
name: Gang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: