Pain
Conditions
Keywords
Pain, Propofol, Dexmedetomidine, Midazolam, Effects of sedation on pain perception.
Brief summary
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).
Detailed description
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.
Interventions
DRUGdexmedetomidine
DRUGmidazolam
DRUGpropofol
Sponsors
American Society of Regional Anesthesia
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects * 19 years or older able to follow study instructions
Exclusion criteria
* Age less than 19 or greater than 40 * Pregnant female * Obesity (BMI \> or =35) * Non-English speaking/reading participants * Sleep apnea * Pulmonary problems such as moderate or severe bronchial asthma * Cardiovascular problems such as hypertension * History of claustrophobia * Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device * Presence of an unremoved bullet or shrapnel in the body * Presence of a prosthetic that is not removable * Presence of a hearing aid needed for hearing * Head girth exceeding that of the head coil used in the magnet * Extensive metalwork on or in teeth, or irremovable false teeth or bridgework * Epilepsy * Chronic analgesic medication * Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles) * History of surgery for which details are unavailable * Allery due to study drugs * History of drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating Change | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine | 28 |
| Midazolam | 27 |
| Propofol | 31 |
| Total | 86 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Midazolam | Propofol | Total |
|---|---|---|---|---|
| Age, Continuous | 24.74 years STANDARD_DEVIATION 4.47 | 24.46 years STANDARD_DEVIATION 4.64 | 25.83 years STANDARD_DEVIATION 5.41 | 25.01 years STANDARD_DEVIATION 4.84 |
| Region of Enrollment United States | 28 participants | 27 participants | 31 participants | 86 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 14 Participants | 45 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 17 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 27 | 0 / 31 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 31 |
Outcome results
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Pain Rating Change | -0.253 units on a scale | Standard Error 0.168 |
| Midazolam | Pain Rating Change | 0.762 units on a scale | Standard Error 0.171 |
| Propofol | Pain Rating Change | -0.346 units on a scale | Standard Error 0.159 |