Lidocaine Administration Using STAR Particles
Condition: Anesthesia, Local
Study type: Interventional

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.
    

Detailed description: 
      The objective of this study is to find out if the combination of STAR particles with numbing
      cream can deliver anesthesia faster than applying the cream 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 cream to work more
      quickly and allow the area to become numb more quickly.

      The study will work towards finding out what combination of numbing cream and STAR particles
      will work more quickly than the numbing cream that is already used in children.

      Participants will have 1 visit when they will apply the numbing gel, have a gel with STAR
      particles mixed in applied, and have a Pin-Prick Pain test done to evaluate the numbing gel.
      The study team will also use a device called a vapometer to measure how much water is being
      lost from the skin at the application site before and after the STAR particle application.
      Participants will have follow-up calls 24 hours, 1 week, and 30 days after the visit to ask
      them about any changes to the skin where the STAR particles were applied.
    

Intervention name(s): LET Gel after STAR Particle Application (Right Arm); LET Gel Application without STAR Particle Application (Left Arm)
Intervention type(s): Device; Other
Intervention description(s): 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 in order to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the mid-forearm at two locations (right antecubital fossa and wrist). Immediately after application of the STAR particles, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine after STAR particle application (TSP) at both sites.; Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying aloe gel (CONTROL) to the volar surface of the mid-forearm at two locations (right antecubital fossa and right wrist). Immediately after application of the aloe gel, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed by the investigator every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine without STAR particle application (TLET) at both sites.
Other intervention name(s): STAR Particle preparation; Aloe Gel; Topical Lidocaine; Control
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STAR particles; Topical Lidocaine; Skin; Pediatrics; Adolescents