Clinical trial NCT01224431: Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
Official title: Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
lidocaine
lumbar puncture
j-tip
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 60
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain, Measured as Units on a Scale
timeFrame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
Secondary outcomes:
measure: Length of Cry
timeFrame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Blake Bulloch/PhoenixChildren's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Childrens Hospital
name: Blake Bulloch, MD
role: STUDY_DIRECTOR
References:
citation: Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.