N/A
N=86
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00853333 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Pain Rating Change — -0.253; 0.762; -0.346 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dexmedetomidine (Drug); midazolam (Drug); propofol (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Rating Change |
-0.253; 0.762; -0.346 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00853333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.