Optimization Lumbar Puncture In Children

NCT02454894 | Withdrawn

• 1 other identifier: 20150206
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation 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, allergy

  up to five days postoperation

Secondary Outcomes (7)

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

  up to four hours postoperation

• degree of adaptability

  intraoperative

• time of lumbar puncture

  intraoperative

• number of puncture

  intraoperative

• success rate

  intraoperative

Study Arms (4)

Group 1

EXPERIMENTAL

no anesthesia; postoperative management

Procedure: postoperative management

Group 2

NO INTERVENTION

no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture

Group 3

EXPERIMENTAL

surface anesthesia with lidocaine; postoperative management

Drug: lidocaine; Procedure: postoperative management

Group 4

EXPERIMENTAL

surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture

Drug: lidocaine

Interventions

lidocaine DRUG

surface anesthesia with lidocaine

Group 3; Group 4

postoperative management PROCEDURE

lying without the pillow for half an hour after lumbar puncture

Group 1; Group 3

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

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gang Liu, MD

  Beijing Childrens' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-05