Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Buffered Lidocaine J-tip

• Registration Number: NCT01224431
• Lead Sponsor: Phoenix Children's Hospital

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Results First Submitted: 2011-04-05
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buffered lidocaine J-tip	Buffered Lidocaine J-tip	Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)
Normal saline J-tip	Buffered Lidocaine J-tip	Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine

Primary Outcome Measures

Name	Time	Method
Pain, Measured as Units on a Scale	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 Outcome Measures

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

Trial Locations

Locations (1)

Blake Bulloch/PhoenixChildren's Hospital; 🇺🇸 Phoenix, Arizona, United States