Pain Perception, Phlebotomy
Conditions
Keywords
venipuncture, phlebotomy, pain perception
Brief summary
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.
Detailed description
The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.
Interventions
DRUG4% lidocaine gel application with sham microneedle device
Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested
Exclusion criteria
cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venipuncture pain levels | 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Undesirable side effects | 1 day |
Countries
United States
Outcome results
None listed