Procedural Pain
Conditions
Brief summary
The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.
Interventions
4%
DRUGBLT
Topical Benzocaine 20%/ Lidocaine 8%/Tetracaine 4%
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women over 18, but not more than 75 years of age. * Patients who have a regularly scheduled dermatology appointment for Intense Pulse Light (IPL), Pulse Dye Laser (PDL), or microneedling.
Exclusion criteria
* Any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine. * Patients with cardiac/respiratory disease, seizure disorder, or neuropathies. * Patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study. * Pregnant women and women who are breastfeeding. * Patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as measured by the Numeric Pain Rating Scale (NPRS) | At baseline | The NPRS pain scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. |
| Pain as measured by the Wong-Baker Face Pain Rating Scale | At baseline | This scale shows a series of six faces ranging from a happy face at no hurt to a crying face at hurts worst. |
Countries
United States
Contacts
Primary ContactNardin Awad, DO
Outcome results
None listed