Anesthesia Lumbar Puncture In Children
ALPIC
1 other identifier
interventional
200
0 countries
N/A
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(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 29, 2015
October 1, 2015
11 months
October 28, 2015
October 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
degree of adaptability
evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
intraoperative
Secondary Outcomes (4)
time of lumbar puncture
intraoperative
number of puncture
intraoperative
success rate
intraoperative
whether bad memories exist or not
up to four hours postoperation
Study Arms (2)
Group 1
EXPERIMENTALsurface anesthesia with lidocaine
Group 2
NO INTERVENTIONno anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- children with indications of lumbar puncture;
- voluntarily signed the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Liu, MD
Beijing Childrens' Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician/Professor
Study Record Dates
First Submitted
October 28, 2015
First Posted
October 29, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 29, 2015
Record last verified: 2015-10