Management Following Lumbar Puncture In Children

Spinal Puncture Complications Clinical Trial

— MFLPIC  

Official title:

Management Following Lumbar Puncture In Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02590718
• Other study ID #: 20150826
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2015
• Last updated: October 28, 2015
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Beijing Children's Hospital
• Contact: Bing Hu, postgraduate
• Email: hubing6028[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Puncture Complications

Intervention

Procedure:
• optimized postoperative management
lying without the pillow for half an hour after lumbar puncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Postoperation complications include headache, backache, vomit, cerebral hernia etc.		up to five days postoperation	No
Secondary	Composite measure of Vital signs include heart rate, pulse, blood pressure and respiration.		up to four hours postoperation	No
Secondary	comfort degree	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale	up to four hours postoperation	No
Secondary	whether bad memories exist or not	A questionaire about the operation for all parents and children will be investigated.	up to four hours postoperation	No