Management Following Lumbar Puncture In Children (MFLPIC)

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Puncture Complications
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.	up to five days postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whether bad memories exist or not	A questionaire about the operation for all parents and children will be investigated.	up to four hours postoperation
Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.		up to four hours postoperation
comfort degree	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale	up to four hours postoperation

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20150826