An interventional study of Buffered Lidocaine J-tip in Pain, sponsored by Phoenix Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 90 Days. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Phoenix Children's Hospital · Not applicable, Interventional, and Treatment
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.
Phoenix Children's Hospital is the lead sponsor of 40 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)
Drug: Buffered Lidocaine 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
Also known as: Normal Saline J-tip
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.
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
| Milestone | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 25 |
| Not completed | 0 | 5 |
| Withdrew: Not randomized | 0 | 4 |
| Withdrew: No video record | 0 | 1 |
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
| units on scale, 0-5 | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection |
|---|---|---|
| Pain, Measured as Units on a Scale | 4.0 ± 1.3 | 4.8 ± 0.5 |
cry video recorded and measured after needle stick until pt stopped crying
| seconds | Buffered Lidocaine J-tip | Normal Saline J-tip |
|---|---|---|
| Length of Cry | 38.53 ± 18.63 | 48.76 ± 16.15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buffered Lidacaine J-tip | — | 0/30 (0%) | 0/30 (0%) |
| Normal Saline J-tip | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection | Total |
|---|---|---|---|
| <=18 years | 30 | 30 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(days) | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection | Total |
|---|---|---|---|
| Mean | 48 ± 15 | 40 ± 18 | 44 ± 17 |
| Sex: Female, Male(Participants) | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection | Total |
|---|---|---|---|
| Female | 16 | 15 | 31 |
| Male | 14 | 15 | 29 |
| Region of Enrollment(participants) | Needleless Injection of Buffered Lidocaine | Normal Saline Via Needleless Injection | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Phoenix Children's Hospital