Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Condition(s) targeted: Pain

Intervention: jtip needleless lidocaine injection (Drug)

Phase: N/A

Status: Completed

Sponsored by: Phoenix Children's Hospital

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.

Official title: Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain, Measured as Units on a Scale

Secondary outcome:

Length of Cry

Heart Rate

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.

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

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

Blake Bulloch/PhoenixChildren's Hospital, Phoenix, Arizona 85018, United States

Starting date: June 2009
Last updated: June 14, 2011