The Effect of Microneedle Pretreatment on Topical Anesthesia

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Microneedle Roller; Device: Sham microneedle Roller

• Registration Number: NCT02596750
• Lead Sponsor: University of California, Davis

Brief Summary

This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.

Detailed Description

This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-10-31
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Results First Submitted: 2017-04-17
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Results First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Healthy volunteers

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Exclusion Criteria

• Allergy to lidocaine
• Smokers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedle Pretreatment	Microneedle Roller	One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.
Sham Microneedle Pretreatment	Sham microneedle Roller	One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain	30 min	100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States