Skip to content

Optimization Lumbar Puncture In Children

Optimization Lumbar Puncture In Children

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02454894
Acronym
OLPIC
Enrollment
0
Registered
2015-05-27
Start date
2015-05-31
Completion date
2016-03-31
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Puncture Complications

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.

Interventions

DRUGlidocaine

surface anesthesia with lidocaine

lying without the pillow for half an hour after lumbar puncture

Sponsors

Beijing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergyup to five days postoperation

Secondary

MeasureTime frameDescription
degree of adaptabilityintraoperativeevaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
time of lumbar punctureintraoperative
number of punctureintraoperative
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.up to four hours postoperation
comfort degreeup to four hours postoperationevaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale
whether bad memories exist or notup to four hours postoperationA questionaire about the operation for all parents and children will be investigated.
success rateintraoperative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026