Status:
COMPLETED
Lidocaine Administration Using STAR Particles
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Anesthesia, Local
Eligibility:
All Genders
10-21 years
Phase:
NA
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 ...
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 microneedl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06034340
Start Date
March 19 2023
End Date
June 13 2023
Last Update
August 20 2024
Active Locations (1)
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1
Emory Children's Center
Atlanta, Georgia, United States, 30322