Kinetic Anesthesia Device Study

University of Pennsylvania

Status: Completed

Conditions: Local Anaesthetic Complication; Pain

Treatments: Device: Kinetic Anesthesia Device; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03344510

828686

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult volunteers greater than or equal to 18 years of age
2. Able and willing to provide informed consent
3. Able to comprehend and comply with study instructions, and able to complete necessary evaluations.

Exclusion criteria

1. Patients unable or unwilling to provide informed consent.
2. Patients with lidocaine allergy
3. Patients with known pain-related or neurological condition.
4. Patients with a known cardiac condition
5. Vulnerable populations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Kinetic anesthesia device, then no intervention

Experimental group

Description:

In this arm of the crossover study, participants will receive lidocaine injection in conjunction with the kinetic anesthesia device, then will receive an injection without the kinetic anesthesia device intervention

Treatment:

Other: Control

Device: Kinetic Anesthesia Device

No intervention, then kinetic anesthesia device

Experimental group

Description:

In this arm of the crossover study, participants will receive lidocaine injection without the kinetic anesthesia device intervention, then will receive an injection in conjunction with the kinetic anesthesia device.

Treatment:

Other: Control

Device: Kinetic Anesthesia Device