Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST)

University of Oklahoma (OU)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Pain Perception; Phlebotomy

Treatments: Drug: Microneedle-facilitated lidocaine application; Drug: 4% lidocaine gel application with sham microneedle device

Study type: Interventional

Funder types: Other

Identifiers

NCT01145326

OUDEM 2010-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Control

Sham Comparator group

Description:

Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Treatment:

Drug: 4% lidocaine gel application with sham microneedle device

Microneedle

Experimental group

Description:

Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Treatment:

Drug: Microneedle-facilitated lidocaine application