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Optimization Lumbar Puncture In Children (OLPIC)

Primary Purpose

Spinal Puncture Complications

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

lidocaine

postoperative management

About this trial

This is an interventional prevention trial for Spinal Puncture Complications

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 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

no anesthesia; postoperative management

no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture

surface anesthesia with lidocaine; postoperative management

surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture

Outcomes

Primary Outcome Measures

Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy

Secondary Outcome Measures

Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.

degree of adaptability

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

time of lumbar puncture

number of puncture

success rate

comfort degree

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

whether bad memories exist or not

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

Full Information

NCT ID

NCT02454894

First Posted

March 13, 2015

Last Updated

October 28, 2015

Sponsor

Beijing Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02454894

Brief Title

Optimization Lumbar Puncture In Children

Acronym

OLPIC

Official Title

Optimization Lumbar Puncture In Children

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Due to the reason that not all participants agree to have anesthesia and postoperative management at the same time

Study Start Date

May 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 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 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.

6. Conditions and Keywords

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

Spinal Puncture Complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

no anesthesia; postoperative management

Arm Title

Group 2

Arm Type

No Intervention

Arm Description

no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture

Arm Title

Group 3

Arm Type

Experimental

Arm Description

surface anesthesia with lidocaine; postoperative management

Arm Title

Group 4

Arm Type

Experimental

Arm Description

surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture

Intervention Type

Drug

Intervention Name(s)

lidocaine

Intervention Description

surface anesthesia with lidocaine

Intervention Type

Procedure

Intervention Name(s)

postoperative management

Intervention Description

lying without the pillow for half an hour after lumbar puncture

Primary Outcome Measure Information:

Title

Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia, allergy

Time Frame

up to five days postoperation

Secondary Outcome Measure Information:

Title

Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.

Time Frame

up to four hours postoperation

Title

degree of adaptability

Description

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

Time Frame

intraoperative

Title

time of lumbar puncture

Time Frame

intraoperative

Title

number of puncture

Time Frame

intraoperative

Title

success rate

Time Frame

intraoperative

Title

comfort degree

Description

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

Time Frame

up to four hours postoperation

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

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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Optimization Lumbar Puncture In Children

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