Trial Outcomes & Findings for Preventing Propofol-associated Injection Pain (NCT NCT00864682)

NCT ID: NCT00864682

Last Updated: 2021-01-27

Results Overview

11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 156 participants
• Primary outcome timeframe: Immediately after injection of study drug. One time assessment.
• Results posted on: 2021-01-27

Participant Flow

Patients entered were recruited between January 2008 and March 2009. Hospital / ambulatory surgery setting

Participant milestones

Measure	Control Arm saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm lidocaine pretreatment, saline plus propofol admixture
Overall Study STARTED	52	51	53
Overall Study COMPLETED	50	50	51
Overall Study NOT COMPLETED	2	1	2

Reasons for withdrawal

Measure	Control Arm saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm lidocaine pretreatment, saline plus propofol admixture
Overall Study Protocol Violation	2	1	2

Baseline Characteristics

Preventing Propofol-associated Injection Pain

Baseline characteristics by cohort

Measure	Control Arm n=52 Participants saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm n=51 Participants saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm n=53 Participants lidocaine pretreatment, saline plus propofol admixture	Total n=156 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	41 Participants n=7 Participants	38 Participants n=5 Participants	121 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	35 Participants n=4 Participants
Age, Continuous	53 years STANDARD_DEVIATION 14 • n=5 Participants	54 years STANDARD_DEVIATION 14 • n=7 Participants	52 years STANDARD_DEVIATION 17 • n=5 Participants	53 years STANDARD_DEVIATION 15 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	79 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	77 Participants n=4 Participants
Region of Enrollment United States	52 participants n=5 Participants	51 participants n=7 Participants	53 participants n=5 Participants	156.0 participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately after injection of study drug. One time assessment.

11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain

Outcome measures

Measure	Control Arm n=50 Participants saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm n=50 Participants saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm n=51 Participants lidocaine pretreatment, saline plus propofol admixture
Verbal Pain Score	3 Units on a scale Interval 0.0 to 6.0	0 Units on a scale Interval 0.0 to 2.0	0 Units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Immediately after injection of study drug. One time assessment

Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)

Outcome measures

Measure	Control Arm n=50 Participants saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm n=50 Participants saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm n=51 Participants lidocaine pretreatment, saline plus propofol admixture
Complete Alleviation of Injection Pain	14 Participants	28 Participants	40 Participants

SECONDARY outcome

Timeframe: Prior to discharge. One time assessment

Were you satisfied with the anesthetic technique? Yes/No

Outcome measures

Measure	Control Arm n=50 Participants saline pretreatment, saline plus propofol admixture	Lidocaine / Propofol Admixture Arm n=50 Participants saline pretreatment, lidocaine plus propofol admixture	Lidocaine Pretreatment Arm n=51 Participants lidocaine pretreatment, saline plus propofol admixture
Satisfaction With Anesthetic Technique Yes	42 Participants	48 Participants	51 Participants
Satisfaction With Anesthetic Technique No	8 Participants	2 Participants	0 Participants

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine / Propofol Admixture Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine Pretreatment Arm

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

Joseph M. Neal, MD

Virginia Mason Medical Center

Phone: 206-223-6980

Email: anejmn@vmmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place