Lidocaine Administration Using STAR Particles

Emory University

Status: Completed

Conditions: Anesthesia, Local

Treatments: Device: LET Gel after STAR Particle Application (Right or Left Arm); Other: LET Gel Application without STAR Particle Application (Contralateral Arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT06034340

STUDY00002928

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application

Experimental group

Description:

Children, adolescents, and young adults will receive local anesthesia with lidocaine-epinephrine-tetracaine (LET) gel via different methods on different arms. One arm will have STAR particles used prior to LET gel and the other arm will have aloe gel applied prior to LET gel.

Treatment:

Other: LET Gel Application without STAR Particle Application (Contralateral Arm)

Device: LET Gel after STAR Particle Application (Right or Left Arm)