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Management Following Lumbar Puncture In Children (MFLPIC)

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ClinicalTrials.gov Identifier: NCT02590718
Recruitment Status : Unknown
Verified October 2015 by Gang Liu, Beijing Children's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Spinal Puncture Complications Procedure: optimized postoperative management

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Management Following Lumbar Puncture In Children
Study Start Date : October 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
optimized postoperative management(lying without the pillow for half an hour after lumbar puncture)
Procedure: optimized postoperative management
lying without the pillow for half an hour after lumbar puncture
No Intervention: Group 2
traditional postoperative management(lying without the pillow and fasting water and food for four hours after lumbar puncture)


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc. [ Time Frame: up to five days postoperation ]

Secondary Outcome Measures :
  1. Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration. [ Time Frame: up to four hours postoperation ]
  2. comfort degree [ Time Frame: up to four hours postoperation ]
    evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale

  3. whether bad memories exist or not [ Time Frame: up to four hours postoperation ]
    A questionaire about the operation for all parents and children will be investigated.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590718


Contacts
Contact: Bing Hu, postgraduate hubing6028@163.com
Contact: Bing Liu, postgraduate 1191009583@163.com

Sponsors and Collaborators
Beijing Children's Hospital
Investigators
Principal Investigator: Gang Liu, MD Beijing Childrens' Hospital
More Information

Responsible Party: Gang Liu, Chief physician/Professor, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02590718     History of Changes
Other Study ID Numbers: 20150826
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015