Kinetic Anesthesia Device Study
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | January 23, 2017 |
| End Date: | May 30, 2018 |
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
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
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
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.
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.
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
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