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Anesthesia Lumbar Puncture In Children (ALPIC)

Capital Medical University logo

Capital Medical University

Status

Unknown

Conditions

Spinal Puncture
Anesthesia

Treatments

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02590705
20150825

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Group 1
Experimental group
Description:
surface anesthesia with lidocaine
Treatment:
Drug: Lidocaine
Group 2
No Intervention group
Description:
no anesthesia

Trial contacts and locations

0

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Central trial contact

Bing Hu, postgraduate; Bing Liu, postgraduate

Data sourced from clinicaltrials.gov

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