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Anesthesia Lumbar Puncture In Children

Anesthesia Lumbar Puncture In Children (ALPIC)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02590705
Acronym
ALPIC
Enrollment
200
Registered
2015-10-29
Start date
2015-10-31
Completion date
2016-09-30
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

Anesthesia, Spinal Puncture

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.

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) and comfortable LP will be established upon completion of this study.

Interventions

DRUGLidocaine

surface anesthesia with lidocaine

Sponsors

Beijing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 frameDescription
degree of adaptabilityintraoperativeevaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Secondary

MeasureTime frameDescription
time of lumbar punctureintraoperative
number of punctureintraoperative
success rateintraoperative
whether bad memories exist or notup to four hours postoperationA questionaire about the operation for all parents and children will be investigated.

Contacts

Primary ContactBing Hu, postgraduate
hubing6028@163.com
Backup ContactBing Liu, postgraduate
1191009583@163.com

Outcome results

None listed

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