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Management Following Lumbar Puncture In Children (MFLPIC)

Primary Purpose

Spinal Puncture Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
optimized postoperative management
Sponsored by
Beijing Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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 Type

    Experimental

    No Intervention

    Arm Label

    Group 1

    Group 2

    Arm Description

    optimized postoperative management(lying without the pillow for half an hour after lumbar puncture)

    traditional postoperative management(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 etc.

    Secondary Outcome Measures

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

    First Posted
    October 28, 2015
    Last Updated
    October 28, 2015
    Sponsor
    Beijing Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02590718
    Brief Title
    Management Following Lumbar Puncture In Children
    Acronym
    MFLPIC
    Official Title
    Management Following Lumbar Puncture In Children
    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
    No

    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 (lying without the pillow and fasting water and food for four hours following lumbar puncture), an optimized postoperative management (lying without the pillow for half an hour following lumbar puncture) is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to assess the degree of pain after lumbar puncture. Any postoperative condition will be recorded and analyzed. A questionaire 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 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 Complications

    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
    optimized postoperative management(lying without the pillow for half an hour after lumbar puncture)
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    traditional postoperative management(lying without the pillow and fasting water and food for four hours after lumbar puncture)
    Intervention Type
    Procedure
    Intervention Name(s)
    optimized 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 etc.
    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
    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
    No
    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
    Email
    hubing6028@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bing Liu, postgraduate
    Email
    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

    Citations:
    PubMed Identifier
    30987603
    Citation
    Hu B, Chen TM, Liu B, Chi W, Miao YQ, Nie XL, Peng XX, Liu G. Optimal management after paediatric lumbar puncture: a randomized controlled trial. BMC Neurol. 2019 Apr 13;19(1):64. doi: 10.1186/s12883-019-1275-9.
    Results Reference
    derived

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    Management Following Lumbar Puncture In Children

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