Management Following Lumbar Puncture In Children

NCT02590718 | Unknown

• 1 other identifier: 20150826
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Puncture Complications

Outcome Measures

Primary Outcomes (1)

• Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.

  up to five days postoperation

Secondary Outcomes (3)

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

  up to four hours postoperation

• comfort degree

  up to four hours postoperation

• whether bad memories exist or not

  up to four hours postoperation

Study Arms (2)

Group 1

EXPERIMENTAL

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

Procedure: optimized postoperative management

Group 2

NO INTERVENTION

traditional postoperative management(lying without the pillow and fasting water and food for four hours after lumbar puncture)

Interventions

optimized postoperative management PROCEDURE

lying without the pillow for half an hour after lumbar puncture

Group 1

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children with indications of lumbar puncture;
• voluntarily signed the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Related Publications (1)

• 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.

  PMID: 30987603 DERIVED

Study Officials

• Gang Liu, MD

  Beijing Childrens' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Hu, postgraduate

CONTACT

hubing6028@163.com

Bing Liu, postgraduate

CONTACT

1191009583@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician/Professor

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10