Clinical trial NCT06034340: Lidocaine Administration Using STAR Particles
Official title: Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Keywords: STAR particles
Topical Lidocaine
Skin
Pediatrics
Adolescents
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2023-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Sharp (as Opposed to Dull) Sensation Over Application Area
timeFrame: Day 1 at 10 minutes or 20 minutes after application of LET gel
measure: Application Site Pain Assessment
timeFrame: Day 1 at 10 minutes or 20 minutes after application of LET gel
Secondary outcomes:
measure: Change in Transepidermal Water Loss (TEWL)
timeFrame: Day 1 at baseline and immediately after application of LET gel
measure: Number of Participants With Acute Skin Reactions (ASRs)
timeFrame: Immediately, 1 hour, 24 hours, and 7 days after application.
measure: Number of Participants Experiencing Adverse Events
timeFrame: Immediately after application, 1 hour after application and up to 1 week after application
measure: Number of Participants Experiencing Serious Adverse Events
timeFrame: Immediately after application, 1 hour after application and up to 1 week after application
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Eric I Felner, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: