Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Buffered Lidocaine J-tip
- Conditions
- Pain
- Sponsor
- Phoenix Children's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain, Measured as Units on a Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
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.
Investigators
Blake Bulloch
MD
Phoenix Children's Hospital
Eligibility 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
Arms & Interventions
Buffered lidocaine J-tip
Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)
Intervention: Buffered Lidocaine J-tip
Normal saline J-tip
Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine
Intervention: Buffered Lidocaine J-tip
Outcomes
Primary Outcomes
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 Outcomes
- Length of Cry(On average the first hour in the emergency department; from needle stick to end of lumbar puncture)