Pain
Conditions
Brief summary
This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.
Detailed description
This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.
Interventions
DEVICEMicroneedle Roller
200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
DEVICESham microneedle Roller
Flat roller without microneedles
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Each subject will serve as his or her own control. The right forearm and the left forearm will be randomized through a binary randomization to determine whether the right arm will receive microneedle treatment or sham microneedle treatment (roller with no microneedles). This randomization is developed through code in Excel that will result in binary result of either the value 0 or 1 for each subject. For those subjects assigned a binary code of 0, the right forearm will receive microneedle treatment and the left forearm will receive sham microneedle treatment. For those subjects assigned a binary code of 1, the left forearm will receive microneedle treatment and the right forearm will receive sham microneedle treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers
Exclusion criteria
* Allergy to lidocaine * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain | 2 min | 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
Countries
United States
Participant flow
Pre-assignment details
Measure Analysis Population Description: This study incorporated a split body design. 21 participants were studied, each participant had a different treatment on each of their forearms, 42 forearms or data points overall.
Participants by arm
| Arm | Count |
|---|---|
| Microneedle Pretreatment One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Microneedle Roller: 200-micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
Topical 4% lidocaine | 21 |
| Microneedle Pretreatment One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Microneedle Roller: 200-micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
Topical 4% lidocaine | 21 |
| Sham Microneedle Pretreatment One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Sham microneedle Roller: Flat roller without microneedles
Topical 4% lidocaine | 21 |
| Sham Microneedle Pretreatment One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 5 min, 10 min, and 30 min time points.
Sham microneedle Roller: Flat roller without microneedles
Topical 4% lidocaine | 21 |
| Total | 84 |
Baseline characteristics
| Characteristic | Microneedle Pretreatment | Sham Microneedle Pretreatment | Total |
|---|---|---|---|
| Age, Continuous | 29 years | 29 years | 29 years |
| Region of Enrollment United States | 21 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Female | 0 Forearms | 0 Forearms | 0 Forearms |
| Sex: Female, Male Male | 21 Forearms | 21 Forearms | 42 Forearms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Visual Analog Scale Pain
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 2 min
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Microneedle Pretreatment 1 Ventral Forearm | Visual Analog Scale Pain | 7 Units on a Scale | Standard Deviation 2 |
| Sham Comparator: Sham Microneedle Pretreatment | Visual Analog Scale Pain | 12 Units on a Scale | Standard Deviation 3 |
Primary
Visual Analog Scale Pain
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 5 min
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Microneedle Pretreatment 1 Ventral Forearm | Visual Analog Scale Pain | 11 Units on a Scale | Standard Deviation 2.5 |
| Sham Comparator: Sham Microneedle Pretreatment | Visual Analog Scale Pain | 15 Units on a Scale | Standard Deviation 4 |
Primary
Visual Analog Scale Pain
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 10 min
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Microneedle Pretreatment 1 Ventral Forearm | Visual Analog Scale Pain | 8 Units on a Scale | Standard Deviation 3 |
| Sham Comparator: Sham Microneedle Pretreatment | Visual Analog Scale Pain | 12.5 Units on a Scale | Standard Deviation 3 |
Primary
Visual Analog Scale Pain
100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 30 min
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator: Microneedle Pretreatment 1 Ventral Forearm | Visual Analog Scale Pain | 4 Units on a Scale | Standard Deviation 1.3 |
| Sham Comparator: Sham Microneedle Pretreatment | Visual Analog Scale Pain | 14.4 Units on a Scale | Standard Deviation 3.8 |