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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buffered lidocaine J-tip | Experimental | Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) |
|
| Normal saline J-tip | Placebo Comparator | Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buffered Lidocaine J-tip | Drug | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blake Bulloch, MD | Phoenix Childrens Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blake Bulloch/PhoenixChildren's Hospital | Phoenix | Arizona | 85018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22743744 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Needleless Injection of Buffered Lidocaine | needleless injection of buffered lidocaine prior to lumbar puncture |
| FG001 | Normal Saline Via Needleless Injection | needleless injection of normal saline prior to lumbar puncture |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Needleless Injection of Buffered Lidocaine | needleless injection of buffered lidocaine prior to lumbar puncture |
| BG001 | Normal Saline Via Needleless Injection | needleless injection of normal saline prior to lumbar puncture |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | 2011 | Mean | Standard Deviation | units on scale, 0-5 | on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buffered Lidacaine J-tip | Experimental: needleless injection of buffered lidocaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelique Ferayorni | Phoenix Children's Hospital | 602-546-1910 | aferayorni@phoenixchildrens.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | In days of age not years | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Length of Cry | cry video recorded and measured after needle stick until pt stopped crying | Posted | Mean | Standard Deviation | seconds | On average the first hour in the emergency department; from needle stick to end of lumbar puncture |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Normal Saline J-tip | Placebo Comparator: normal saline via needleless injection | 0 | 30 | 0 | 30 |
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