Anesthesia, Local
Conditions
Keywords
STAR particles, Topical Lidocaine, Skin, Pediatrics, Adolescents
Brief summary
This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a specific area? Research participants will provide feedback on how quickly the STAR particles with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.
Detailed description
This study aims to find out if the combination of STAR particles with numbing gel can deliver anesthesia faster than applying the gel by itself. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for the numbing gel to work more quickly and allow the area to become numb more quickly. After pretreatment with STAR particles (applied to the right or left arm) and aloe gel (used as a control condition in the contralateral arm) a numbing gel will be applied. A Pin-Prick test will be performed to evaluate local anesthesia from the numbing gel; half the participants will be evaluated 10 minutes after application of the numbing gel and the other half will be assessed 20 minutes after the numbing gel is applied. The study team will also assess pain after needle insertion and measure how much water is being lost from the skin using a device called a Vapometer before and after the STAR particle and aloe gel applications. Participants will have follow-up calls 24 hours and 1 week after the visit to ask about any changes to the skin where the STAR particles were applied.
Interventions
DEVICELET Gel after STAR Particle Application (Right or Left Arm)
STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa.
OTHERLET Gel Application without STAR Particle Application (Contralateral Arm)
Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation.
Sponsors
Children's Healthcare of Atlanta
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Children, adolescents, and young adults, 10 to 21 years of age * In good general health as determined by a medical history * Willing to provide informed assent with parental consent and follow study requirements
Exclusion criteria
* Is chronically using pain medication * Has a plan to move to another location in the next 12 months or foresees any other reason that participation in the study would be disrupted during the next 12 months * Has skin disorders or skin allergies * Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium Dioxide) * Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application * Has known neurological conditions that might affect sensory function or perception of pain * Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Sharp (as Opposed to Dull) Sensation Over Application Area | Day 1 at 10 minutes or 20 minutes after application of LET gel | The time to achieve anesthesia is assessed as the percent of sharp (as opposed to dull) sensation reported at 10 or 20 minutes after the application of LET gel. |
| Application Site Pain Assessment | Day 1 at 10 minutes or 20 minutes after application of LET gel | The application site pain assessment was measured by using the visual analog scale (VAS). The VAS consists of a 10 centimeter (cm) line with opposite endpoints representing no pain (coded as 0) and pain as bad as it could possibly be (coded as 10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Day 1 at baseline and immediately after application of LET gel | The transepidermal water loss (TEWL) was measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel. |
| Number of Participants With Acute Skin Reactions (ASRs) | Immediately, 1 hour, 24 hours, and 7 days after application. | Participants were observed for acute skin reactions at each application site on both arms. |
| Number of Participants Experiencing Adverse Events | Immediately after application, 1 hour after application and up to 1 week after application | All adverse events were documented starting immediately after lidocaine application up to 1 week after application. |
| Number of Participants Experiencing Serious Adverse Events | Immediately after application, 1 hour after application and up to 1 week after application | All serious adverse events were documented starting immediately after lidocaine application up to one week after application. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Children's Healthcare of Atlanta (CHOA) at Egleston in Atlanta, Georgia, USA. Participant enrollment began March 19, 2023, and all follow-up assessments were complete by June 13, 2023.
Pre-assignment details
All participants received local anesthesia with LET gel via different methods on different arms. One arm had STAR particles applied before LET gel and the other had aloe gel (the control condition) applied before LET gel. Assessments for sharp sensation and pain took place at 10 minutes for half (11) of the participants and at 20 minutes for the other half (11) of the participants.
Participants by arm
| Arm | Count |
|---|---|
| ALL PARTICIPANTS All participants received local anesthesia with LETgel via different methods on different arms. One arm had STAR particles applied before LET gel and the contralateral had aloe gel (the control condition) applied before LET gel. Half of the participants (after both applications) were evaluated for sharp sensation and site pain at 10 or 20 minutes after applying the LET gel.
STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles will vary in concentration and length to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) was applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa. For the control condition, topical lidocaine (0.5grams of Lidocaine in LET gel) was applied immediately after applying aloe gel to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | ALL PARTICIPANTS |
|---|---|
| Age, Continuous | 13.36 years STANDARD_DEVIATION 1.72 |
| Body Mass Index (BMI) | 20.2 kg/m^2 STANDARD_DEVIATION 3.8 |
| Body Surface Area (BSA) | 1.47 square meters (m^2) STANDARD_DEVIATION 0.24 |
| Height | 156.7 centimeters (cm) STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Mixed (Black/White) | 2 Participants |
| Race/Ethnicity, Customized Mixed (Pacific Islander/White) | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 16 Participants |
| Weight | 50.3 kilograms (kg) STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Application Site Pain Assessment
The application site pain assessment was measured by using the visual analog scale (VAS). The VAS consists of a 10 centimeter (cm) line with opposite endpoints representing no pain (coded as 0) and pain as bad as it could possibly be (coded as 10).
Time frame: Day 1 at 10 minutes or 20 minutes after application of LET gel
Population: All 22 participants had STARS applied before the LET gel on either arm and Aloe (Control) gel was applied before the LET gel on the opposite arm. Half of the participants were assessed for sharp sensation at 10 minutes and the other half were evaluated 20 minutes after the application of LET gel in both participants' arms (STAR particle and aloe (Control) gel pretreatment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Application Site Pain Assessment | VAS at 10 minutes post-applications | 3.09 score on a scale | Standard Error 1.83 |
| LET Gel After STAR Particle Application (Right or Left Arm) | Application Site Pain Assessment | VAS at 20 minutes post-applications | 4.18 score on a scale | Standard Error 0.96 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Application Site Pain Assessment | VAS at 20 minutes post-applications | 5.32 score on a scale | Standard Error 1.47 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Application Site Pain Assessment | VAS at 10 minutes post-applications | 4.09 score on a scale | Standard Error 1.92 |
Primary
Percent of Sharp (as Opposed to Dull) Sensation Over Application Area
The time to achieve anesthesia is assessed as the percent of sharp (as opposed to dull) sensation reported at 10 or 20 minutes after the application of LET gel.
Time frame: Day 1 at 10 minutes or 20 minutes after application of LET gel
Population: All 22 participants had STARS applied before the LET gel on either arm and Aloe (Control) gel was applied before the LET gel on the opposite arm. Half of the participants were assessed for sharp sensation at 10 minutes and the other half were evaluated 20 minutes after the application of LET gel in both participants' arms (STAR particle and aloe (Control) gel pretreatment).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Percent of Sharp (as Opposed to Dull) Sensation Over Application Area | Assessment of the area at 10 minutes post applications | 51.6 Percentage of area with sharp sensation | Standard Error 29.32 |
| LET Gel After STAR Particle Application (Right or Left Arm) | Percent of Sharp (as Opposed to Dull) Sensation Over Application Area | Assessment of the area at 20 minutes post applications | 55.7 Percentage of area with sharp sensation | Standard Error 21.8 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Percent of Sharp (as Opposed to Dull) Sensation Over Application Area | Assessment of the area at 10 minutes post applications | 82.0 Percentage of area with sharp sensation | Standard Error 18.6 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Percent of Sharp (as Opposed to Dull) Sensation Over Application Area | Assessment of the area at 20 minutes post applications | 89.0 Percentage of area with sharp sensation | Standard Error 15.6 |
Secondary
Change in Transepidermal Water Loss (TEWL)
The transepidermal water loss (TEWL) was measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel.
Time frame: Day 1 at baseline and immediately after application of LET gel
Population: All 22 participants underwent TEWL measurements before and after the STAR and aloe (Control) gel applications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Change in Transepidermal Water Loss (TEWL) | 25.0 g/m^2/hr | Standard Error 8.7 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Change in Transepidermal Water Loss (TEWL) | 14.8 g/m^2/hr | Standard Error 4.3 |
Secondary
Number of Participants Experiencing Adverse Events
All adverse events were documented starting immediately after lidocaine application up to 1 week after application.
Time frame: Immediately after application, 1 hour after application and up to 1 week after application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Number of Participants Experiencing Adverse Events | 0 Participants |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Number of Participants Experiencing Adverse Events | 0 Participants |
Secondary
Number of Participants Experiencing Serious Adverse Events
All serious adverse events were documented starting immediately after lidocaine application up to one week after application.
Time frame: Immediately after application, 1 hour after application and up to 1 week after application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Number of Participants Experiencing Serious Adverse Events | 0 Participants |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Number of Participants Experiencing Serious Adverse Events | 0 Participants |
Secondary
Number of Participants With Acute Skin Reactions (ASRs)
Participants were observed for acute skin reactions at each application site on both arms.
Time frame: Immediately, 1 hour, 24 hours, and 7 days after application.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | Number of Participants With Acute Skin Reactions (ASRs) | 0 Participants |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | Number of Participants With Acute Skin Reactions (ASRs) | 0 Participants |