Kinetic Anesthesia Device Study

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Kinetic anesthesia device, then no intervention	Kinetic Anesthesia Device	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
No intervention, then kinetic anesthesia device	Kinetic Anesthesia Device	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.
Kinetic anesthesia device, then no intervention	Control	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
No intervention, then kinetic anesthesia device	Control	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.

Primary Outcome Measures

Name	Time	Method
Pain of Lidocaine Injection, Measured by Visual Analog Scale.	This measurement will occur immediately after each injection	Participants will be asked to mark the pain of injection on a 100mm visual analog scale. The visual analog scale is commonly used to measure acute pain, though it can be used in other settings. It consists of a line 100mm long. The left end is labeled "no pain at all" and the right end is labeled "worst pain imaginable." Participants will rate pain by marking the scale where they feel that their level of pain falls on the scale. The length from 0 to the participant's mark will be measured in millimeters (for a range of 0 to 100 mm possible). Higher numbers will be considered more pain.

Secondary Outcome Measures

Name	Time	Method
Patient Preference for Injection With or Without Kinetic Anesthesia Device	This will occur immediately after the second injection	Qualitative measure of patient preference for injections with or without the kinetic anesthesia device. Participants were asked whether they preferred the injection with or without the kinetic anesthesia device. Counts below indicate the number of participants who preferred each type of injection.

Locations (1): Perelman Center for Advanced Medicine
🇺🇸
Philadelphia, Pennsylvania, United States