Clinical trial NCT02590718: Management Following Lumbar Puncture In Children
Official title: Management Following Lumbar Puncture In Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Puncture Complications
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 etc.
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: 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:
citation: Hu B, Chen TM, Liu B, Chi W, Miao YQ, Nie XL, Peng XX, Liu G. Optimal management after paediatric lumbar puncture: a randomized controlled trial. BMC Neurol. 2019 Apr 13;19(1):64. doi: 10.1186/s12883-019-1275-9.