An interventional study of dexmedetomidine and midazolam in Pain, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by University of Alabama at Birmingham · Not applicable and Interventional
The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).
We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 86 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University of Alabama at Birmingham is the lead sponsor of 1,415 studies on the registry; 277 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
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Healthy subjects
Exclusion Criteria:
Administration via an IV
Drug: propofol
Administration via an IV
Drug: midazolam
Administration via an IV
Drug: dexmedetomidine
Pain Rating Change
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.
Time frame: Sedation
| Milestone | Dexmedetomidine | Midazolam | Propofol |
|---|---|---|---|
| Started | 28 | 27 | 31 |
| Completed | 28 | 27 | 31 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Dexmedetomidine | Midazolam | Propofol |
|---|---|---|---|
| Pain Rating Change | -0.253 ± 0.168 | 0.762 ± 0.171 | -0.346 ± 0.159 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | — | 0/28 (0%) | 0/28 (0%) |
| Midazolam | — | 0/27 (0%) | 0/27 (0%) |
| Propofol | — | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Dexmedetomidine | Midazolam | Propofol | Total |
|---|---|---|---|---|
| Mean | 24.74 ± 4.47 | 24.46 ± 4.64 | 25.83 ± 5.41 | 25.01 ± 4.84 |
| Sex: Female, Male(Participants) | Dexmedetomidine | Midazolam | Propofol | Total |
|---|---|---|---|---|
| Female | 15 | 16 | 14 | 45 |
| Male | 13 | 11 | 17 | 41 |
| Region of Enrollment(participants) | Dexmedetomidine | Midazolam | Propofol | Total |
|---|---|---|---|---|
| United States | 28 | 27 | 31 | 86 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Midazolam · Propofol
University of Alabama at Birmingham →