Trial Outcomes & Findings for Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain (NCT NCT03057704)

Last Updated: 2018-09-10

Results Overview

Patient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

During injection at beginning of study; lasts 10 seconds one time only

Results posted on

2018-09-10

Participant Flow

Subjects were approached after they were scheduled for colonoscopy or minor procedures and appeared in the holding area for procedures in which propofol sedation or induction of general anesthesia was used.

Participant milestones

Participant milestones
Measure	Intravenous Lidocaine: Flushed Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.	Intravenous Lidocaine: Tourniquet Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Lidocaine: Flushed n=25 Participants Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.	Intravenous Lidocaine: Tourniquet n=25 Participants Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 6.9 • n=5 Participants	54 years STANDARD_DEVIATION 7.3 • n=7 Participants	53 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Pain score at IV prior to procedure IV pain score of 0	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Pain score at IV prior to procedure IV pain score of 1-3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: During injection at beginning of study; lasts 10 seconds one time only

Outcome measures

Outcome measures
Measure	Intravenous Lidocaine: Flushed n=25 Participants Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.	Intravenous Lidocaine: Tourniquet n=25 Participants Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet
Patient Expression of Pain	0.76 units on a scale Standard Deviation 1.0	0.04 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only

Investigator asks patient if they recall discomfort during injection after the procedure. Patient's verbal rating and recall of pain during injection. We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

Outcome measures

Outcome measures
Measure	Intravenous Lidocaine: Flushed n=25 Participants Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.	Intravenous Lidocaine: Tourniquet n=25 Participants Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet
Subject's Recall of Injection Discomfort	0.52 units on a scale Standard Deviation 0.82	0.04 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: During injection at beginning of study period; lasts 10 seconds one time only

Investigator rates patient's nonverbal display of discomfort. Investigator Assessments: Induction Discomfort Scale (during injection and within 5 seconds after injection) * No change in patient behavior (0) * Grimace (1) * IV forearm withdrawal (2) * Moaning (3) * Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.

Outcome measures

Outcome measures
Measure	Intravenous Lidocaine: Flushed n=25 Participants Lidocaine injection flushed Lidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.	Intravenous Lidocaine: Tourniquet n=25 Participants Lidocaine injection tourniquet Lidocaine injection tourniquet: Intravenous lidocaine: tourniquet
Investigators Rating of Patient Discomfort	1.12 units on a scale Standard Deviation 1.27	0 units on a scale Standard Deviation 0

Adverse Events

Intravenous Lidocaine: Flushed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Lidocaine: Tourniquet

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

Timothy N. Harwood MD

Wake Forest University School of Medcine

Phone: 3367164498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place