Trial Outcomes & Findings for Sedation and Pain (The Effect of IV Sedation on Pain Perception) (NCT NCT00853333)

Results Overview

Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale. Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

Sedation

Results posted on

2014-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.	Midazolam Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.	Propofol Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
Overall Study STARTED	28	27	31
Overall Study COMPLETED	28	27	31
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=28 Participants	Midazolam n=27 Participants	Propofol n=31 Participants	Total n=86 Participants Total of all reporting groups
Age, Continuous	24.74 years STANDARD_DEVIATION 4.47 • n=5 Participants	24.46 years STANDARD_DEVIATION 4.64 • n=7 Participants	25.83 years STANDARD_DEVIATION 5.41 • n=5 Participants	25.01 years STANDARD_DEVIATION 4.84 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants	41 Participants n=4 Participants
Region of Enrollment United States	28 participants n=5 Participants	27 participants n=7 Participants	31 participants n=5 Participants	86 participants n=4 Participants

PRIMARY outcome

Timeframe: Sedation

Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale. Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=28 Participants	Midazolam n=27 Participants	Propofol n=31 Participants
Pain Rating Change	-0.253 units on a scale Standard Error 0.168	0.762 units on a scale Standard Error 0.171	-0.346 units on a scale Standard Error 0.159

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

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

Michael Froelich

University of Alabama at Birmigham

Phone: (205)975-0145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place