Optimization Lumbar Puncture In Children (OLPIC)

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Puncture Complications
• Intervention / Treatment: Procedure: postoperative management; Drug: lidocaine

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 painless lumbar puncture (LP),less postoperative complications and comfortable LP will be anticipated.

• Study Type: Interventional
• 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: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; no anesthesia; postoperative management	Procedure: postoperative management; lying without the pillow for half an hour after lumbar puncture
No Intervention: Group 2; no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture
Experimental: Group 3; surface anesthesia with lidocaine; postoperative management	Procedure: postoperative management; lying without the pillow for half an hour after lumbar puncture; Drug: lidocaine; surface anesthesia with lidocaine
Experimental: Group 4; surface anesthesia with lidocaine; lying without the pillow and fasting water and food for four hours after lumbar puncture	Drug: lidocaine; surface anesthesia with lidocaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of adaptability	evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale	intraoperative
time of lumbar puncture		intraoperative
number of puncture		intraoperative
success rate		intraoperative
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

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 20150206