Comparison of Compounded Topical Anesthetics

Phase 4RecruitingNCT06569537

Dartmouth-Hitchcock Medical Center64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Procedural Pain

Interventions

Lidocaine topicalDRUG

BLTDRUG

Topical Benzocaine 20%/ Lidocaine 8%/Tetracaine 4%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dartmouth Hitchcock Dermatology Clinic

Lebanon, New Hampshire, United States

RECRUITING

Outcomes

Primary Outcomes

Pain as measured by the Numeric Pain Rating Scale (NPRS)

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.

Time frame: At baseline

Pain as measured by the Wong-Baker Face Pain Rating Scale

This scale shows a series of six faces ranging from a happy face at "no hurt" to a crying face at "hurts worst".

Time frame: At baseline

Central Contacts

Nardin Awad, DO

CONTACT

6036532209 nardin.awad@hitchcock.org

Data from ClinicalTrials.gov

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