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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Buffered Lidocaine J-tip

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Buffered lidocaine J-tip; Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)	Drug: Buffered Lidocaine J-tip; 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 Names: Normal Saline J-tip
PLACEBO_COMPARATOR: Normal saline J-tip; Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine	Drug: Buffered Lidocaine J-tip; 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 Names: Normal Saline J-tip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Measured as Units on a Scale	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	on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Study Director: Blake Bulloch, MD, Phoenix Childrens Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (ESTIMATE): October 20, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: pain; lidocaine; lumbar puncture; j-tip
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 09-014