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

This study has been completed.
Sponsor:
Collaborator:
American Society of Regional Anesthesia
Information provided by (Responsible Party):
Michael Froelich, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00853333
First received: February 26, 2009
Last updated: June 24, 2014
Last verified: June 2014

February 26, 2009
June 24, 2014
November 2008
January 2012   (final data collection date for primary outcome measure)
Pain Rating Change [ Time Frame: Sedation ] [ Designated as safety issue: No ]

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.

Brain activity and pain scores [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853333 on ClinicalTrials.gov Archive Site
Not Provided
Pain variability [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Sedation and Pain (The Effect of IV Sedation on Pain Perception)

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Pain
  • Drug: dexmedetomidine
  • Drug: midazolam
  • Drug: propofol
  • Active Comparator: Propofol
    Administration via an IV
    Intervention: Drug: propofol
  • Active Comparator: Midazolam
    Administration via an IV
    Intervention: Drug: midazolam
  • Active Comparator: Dexmedetomidine
    Administration via an IV
    Intervention: Drug: dexmedetomidine
Frölich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853333
F081016014
Yes
Michael Froelich, University of Alabama at Birmingham
University of Alabama at Birmingham
American Society of Regional Anesthesia
Principal Investigator: Michael A Froelich, M.D. University of Alabama at Birmingham
University of Alabama at Birmingham
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP