Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

This study has been completed.
Sponsor:
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01224431
First received: September 30, 2010
Last updated: June 14, 2011
Last verified: June 2011

September 30, 2010
June 14, 2011
June 2009
June 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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
Pain [ Time Frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. ] [ Designated as safety issue: No ]
Pain scores at time of needle insertion using neonatoal facial coding score.
Complete list of historical versions of study NCT01224431 on ClinicalTrials.gov Archive Site
  • Length of Cry [ Time Frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    patient on Cardiopulmonary monitoring
Same as current
Not Provided
Not Provided
 
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
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
  • Experimental: needleless injection of buffered lidocaine
    needleless injection of buffered lidocaine prior to lumbar puncture
    Intervention: Drug: jtip needleless lidocaine injection
  • Placebo Comparator: normal saline via needleless injection
    needleless injection of normal saline prior to lumbar puncture
    Intervention: Drug: jtip needleless lidocaine injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
up to 90 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224431
09-014
No
Angelique Ferayorni/ Blake Bulloch, Phoenix Children's Hospital
Phoenix Children's Hospital
Not Provided
Not Provided
Phoenix Children's Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP