Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Buffered Lidocaine J-tip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buffered lidocaine J-tip<br>Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) | Drug: Buffered Lidocaine J-tip<br>* 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<br>* Other names: Normal Saline J-tip;|
| Placebo Comparator: Normal saline J-tip<br>Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine | Drug: Buffered Lidocaine J-tip<br>* 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<br>* Other names: Normal Saline J-tip;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, lidocaine, lumbar puncture, j-tip