NCT03344510

Kinetic Anesthesia Device Study

Kinetic Anesthesia Device for Lidocaine Injection: a Randomized Split-body Study of the Effects of Kinetic Anesthesia Devices on Pain of Lidocaine Injection in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. We will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

Detailed description

The study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the University of Pennsylvania, and from the University City area of Philadelphia. Participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. Participants will then be randomized to receive injection with the KAD first or second. The injection will be 0.5 cc of room temperature buffered lidocaine injected at constant slow speed (approximately 5 seconds) through a 30-gage needle held perpendicular to the skin by the same surgeon, with verbal cues standardized. Injections will be given in accordance with the standard of practice. When the KAD is used it will be used as directed: firmly pressed on the skin adjacent to the injection, with the needle aimed into the lighted area. Volunteers will evaluate each injection immediately after it is complete using the visual analog scale. When both injections are completed, participants will indicate their preference of injection, complete qualitative questions, and note necessary demographic information. Injection location and order of intervention (i.e. first or second) will be noted.

Conditions

• Local Anaesthetic Complication
• Pain

Interventions

Type	Name	Description
DEVICE	Kinetic Anesthesia Device	A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain
OTHER	Control	One injection will be administered without the kinetic anesthesia device.

Timeline

• Start date: 2017-01-23
• Primary completion: 2018-01-27
• Completion: 2018-05-30
• First posted: 2017-11-17
• Last updated: 2019-04-02
• Results posted: 2019-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study