Clinical trial NCT03344510: Kinetic Anesthesia Device Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anaesthetic Complication
Pain
Keywords: lidocaine
vibration
anesthesia
injection
pain
discomfort
dermatology
dermatologic surgery
local
device
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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. They will receive one injection with and one injection without the interventional device, in a randomized order.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain of Lidocaine Injection, Measured by Visual Analog Scale.
timeFrame: This measurement will occur immediately after each injection
Secondary outcomes:
measure: Patient Preference for Injection With or Without Kinetic Anesthesia Device
timeFrame: This will occur immediately after the second injection
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Joseph F Sobanko, MD
role: PRINCIPAL_INVESTIGATOR
References: