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Anesthesia Lumbar Puncture In Children (ALPIC)

Primary Purpose

Spinal Puncture, Anesthesia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lidocaine

About this trial

This is an interventional prevention trial for Spinal Puncture

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1

Group 2

Arm Description

surface anesthesia with lidocaine

no anesthesia

Outcomes

Primary Outcome Measures

degree of adaptability

evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Secondary Outcome Measures

time of lumbar puncture

number of puncture

success rate

whether bad memories exist or not

A questionaire about the operation for all parents and children will be investigated.

Full Information

NCT ID

NCT02590705

First Posted

October 28, 2015

Last Updated

October 28, 2015

Sponsor

Beijing Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02590705

Brief Title

Anesthesia Lumbar Puncture In Children

Acronym

ALPIC

Official Title

Anesthesia Lumbar Puncture In Children (ALPIC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Puncture, Anesthesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

surface anesthesia with lidocaine

Arm Title

Group 2

Arm Type

No Intervention

Arm Description

no anesthesia

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

surface anesthesia with lidocaine

Primary Outcome Measure Information:

Title

degree of adaptability

Description

evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

time of lumbar puncture

Time Frame

intraoperative

Title

number of puncture

Time Frame

intraoperative

Title

success rate

Time Frame

intraoperative

Title

whether bad memories exist or not

Description

A questionaire about the operation for all parents and children will be investigated.

Time Frame

up to four hours postoperation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Hu, postgraduate

hubing6028@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Liu, postgraduate

1191009583@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Liu, MD

Organizational Affiliation

Beijing Childrens' Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Anesthesia Lumbar Puncture In Children

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