Trial Outcomes & Findings for Kinetic Anesthesia Device Study (NCT NCT03344510)

Last Updated: 2019-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

This measurement will occur immediately after each injection

Results posted on

2019-04-02

Participant Flow

Healthy volunteers were recruited from the area surrounding the University of Pennsylvania using IRB-approved flyers, as well as approved email communications, and postings on an approved website

This was a split body study, so each participant functioned in both intervention and control arms.

Participant milestones

Participant milestones
Measure	Kinetic Anesthesia Device, Then no Intervention 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 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.
First Injection (5 Minutes) STARTED	21	26
First Injection (5 Minutes) Received Injection	21	26
First Injection (5 Minutes) COMPLETED	21	26
First Injection (5 Minutes) NOT COMPLETED	0	0
Wash Out (10 Minutes STARTED	21	26
Wash Out (10 Minutes COMPLETED	21	26
Wash Out (10 Minutes NOT COMPLETED	0	0
Second Injection (5 Minutes) STARTED	21	26
Second Injection (5 Minutes) Received Injection	21	26
Second Injection (5 Minutes) COMPLETED	21	26
Second Injection (5 Minutes) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Kinetic Anesthesia Device Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=47 Participants All participants received two lidocaine injections - one on the left and one on the right side of the body, with the left side injection always administered first. One of the injections was performed with the kinetic anesthesia device assistance, while the other was performed without (the control injection). As noted in the protocol, participants were randomized to receive the kinetic anesthesia device assisted injection first or second. 21 participants received the kinetic anesthesia device assisted injection first, while 26 were randomized to receive it second. 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
Age, Continuous	26 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified race and ethnicity · White (non-hispanic)	20 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified race and ethnicity · Asian	13 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified race and ethnicity · White (hispanic)	8 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified race and ethnicity · African-American	5 Participants n=5 Participants
Race/Ethnicity, Customized Self-identified race and ethnicity · Native American	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: This measurement will occur immediately after each injection

Population: See above

Outcome measures

Outcome measures
Measure	Injections Using the Kinetic Anesthesia Device n=47 Participants Participants graded the pain of lidocaine injection perfomed in conjunction with the kinetic anesthesia 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	Injections Without Kinetic Anesthesia Device n=47 Participants Participants graded the pain of lidocaine injection with no intervention
Pain of Lidocaine Injection, Measured by Visual Analog Scale.	7.5 mm on visual analog scale Interval 5.0 to 16.0	26 mm on visual analog scale Interval 13.0 to 34.0

SECONDARY outcome

Timeframe: This will occur immediately after the second injection

Population: 45 participants filled out this portion of the post-injection questionnaire, while two neglected this portion of the questionnaire.

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.

Outcome measures

Outcome measures
Measure	Injections Using the Kinetic Anesthesia Device n=45 Participants Participants graded the pain of lidocaine injection perfomed in conjunction with the kinetic anesthesia 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	Injections Without Kinetic Anesthesia Device n=45 Participants Participants graded the pain of lidocaine injection with no intervention
Patient Preference for Injection With or Without Kinetic Anesthesia Device	33 Participants	6 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Sobanko

Perelman School of Medicine at the University of Pennsylvania

Phone: 215.360.0909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place