Pain
Conditions
Keywords
pain, lidocaine, lumbar puncture, j-tip
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.
Interventions
DRUGBuffered 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
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Needleless Injection of Buffered Lidocaine needleless injection of buffered lidocaine prior to lumbar puncture | 30 |
| Normal Saline Via Needleless Injection needleless injection of normal saline prior to lumbar puncture | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not randomized | 0 | 4 |
| Overall Study | no video record | 0 | 1 |
Baseline characteristics
| Characteristic | Normal Saline Via Needleless Injection | Needleless Injection of Buffered Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 40 days STANDARD_DEVIATION 18 | 48 days STANDARD_DEVIATION 15 | 44 days STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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
Time frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Needleless Injection of Buffered Lidocaine | Pain, Measured as Units on a Scale | 4.0 units on scale, 0-5 | Standard Deviation 1.3 |
| Normal Saline Via Needleless Injection | Pain, Measured as Units on a Scale | 4.8 units on scale, 0-5 | Standard Deviation 0.5 |
Secondary
Length of Cry
cry video recorded and measured after needle stick until pt stopped crying
Time frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Needleless Injection of Buffered Lidocaine | Length of Cry | 38.53 seconds | Standard Deviation 18.63 |
| Normal Saline Via Needleless Injection | Length of Cry | 48.76 seconds | Standard Deviation 16.15 |