Trial Outcomes & Findings for Vibration Analgesia in Propofol Infusion During Anesthesia Induction (NCT NCT03509857)

Results Overview

Patient pain will be assessed by two independent observers, an attending anesthesiologist and a certified registered nurse anesthetist (CRNA). Pain was graded using a four-point pain manifestation scale described by McCrirrick \& Hunter : 0 = none (negative response to questioning), 1 = mild (pain reported in response to questioning only, without any behavioral signs), 2 = moderate (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3 = severe (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). Higher scores meaning worse outcome (perceived pain) and lower score meaning better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Day 1 at time of propofol injection

Results posted on

2022-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group normal standard of care infusion of propofol without analgesia	Treatment Group Infusion of propofol with vibration analgesia
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=50 Participants normal standard of care infusion of propofol without analgesia	Treatment Group n=50 Participants Infusion of propofol with vibration analgesia	Total n=100 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 14.2 • n=50 Participants	50 years STANDARD_DEVIATION 13.7 • n=50 Participants	50.7 years STANDARD_DEVIATION 13.9 • n=100 Participants
Sex: Female, Male Female	30 Participants n=50 Participants	30 Participants n=50 Participants	60 Participants n=100 Participants
Sex: Female, Male Male	20 Participants n=50 Participants	20 Participants n=50 Participants	40 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants
Body Mass Index	30.9 kg/m^2 STANDARD_DEVIATION 9.3 • n=50 Participants	29.4 kg/m^2 STANDARD_DEVIATION 5.2 • n=50 Participants	30.2 kg/m^2 STANDARD_DEVIATION 7.5 • n=100 Participants

PRIMARY outcome

Timeframe: Day 1 at time of propofol injection

Patient pain will be assessed by two independent observers, an attending anesthesiologist and a certified registered nurse anesthetist (CRNA). Pain was graded using a four-point pain manifestation scale described by McCrirrick \& Hunter : 0 = none (negative response to questioning), 1 = mild (pain reported in response to questioning only, without any behavioral signs), 2 = moderate (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3 = severe (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). Higher scores meaning worse outcome (perceived pain) and lower score meaning better outcome.

Outcome measures

Outcome measures
Measure	Control Group n=50 Participants normal standard of care infusion of propofol without analgesia	Treatment Group n=50 Participants Infusion of propofol with vibration analgesia
Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct	3.1 units on a scale Standard Deviation 1.6	1.4 units on a scale Standard Deviation 0.5

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

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. Aravind Pothula

Montefiore MC

Phone: 9178015577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place