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Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224431
First Posted: October 20, 2010
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Blake Bulloch, Phoenix Children's Hospital
  Purpose

Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.


Condition Intervention
Pain Drug: jtip needleless lidocaine injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Blake Bulloch, Phoenix Children's Hospital:

Primary Outcome Measures:
  • Pain, Measured as Units on a Scale [ Time Frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. ]
    Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible


Secondary Outcome Measures:
  • Length of Cry [ Time Frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture ]
    cry video recorded and measured after needle stick until pt stopped crying

  • Heart Rate [ Time Frame: On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure. ]
    patient on Cardiopulmonary monitoring


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: needleless injection of buffered lidocaine
needleless injection of buffered lidocaine prior to lumbar puncture
Drug: jtip needleless lidocaine injection
All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection
Placebo Comparator: normal saline via needleless injection
needleless injection of normal saline prior to lumbar puncture
Drug: jtip needleless lidocaine injection
All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection

Detailed Description:

Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fever in infants less than 3 months

Exclusion Criteria:

  • toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224431


Locations
United States, Arizona
Blake Bulloch/PhoenixChildren's Hospital
Phoenix, Arizona, United States, 85018
Sponsors and Collaborators
Phoenix Children's Hospital
  More Information

Responsible Party: Blake Bulloch, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01224431     History of Changes
Other Study ID Numbers: 09-014
First Submitted: September 30, 2010
First Posted: October 20, 2010
Results First Submitted: April 5, 2011
Results First Posted: June 14, 2011
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Blake Bulloch, Phoenix Children's Hospital:
pain
lidocaine
lumbar puncture
j-tip

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action