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

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

Condition Intervention
Drug: dexmedetomidine
Drug: midazolam
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Pain Rating Change [ Time Frame: Sedation ]

    Mechanical Slide Algometer (, Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale.

    Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention.

Enrollment: 86
Study Start Date: November 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Administration via an IV
Drug: propofol
Active Comparator: Midazolam
Administration via an IV
Drug: midazolam
Active Comparator: Dexmedetomidine
Administration via an IV
Drug: dexmedetomidine

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.

Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00853333

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
American Society of Regional Anesthesia
Principal Investigator: Michael A Froelich, M.D. University of Alabama at Birmingham
  More Information

Responsible Party: Michael Froelich, M.D., University of Alabama at Birmingham Identifier: NCT00853333     History of Changes
Other Study ID Numbers: F081016014
Study First Received: February 26, 2009
Results First Received: August 23, 2013
Last Updated: June 24, 2014

Keywords provided by University of Alabama at Birmingham:
Effects of sedation on pain perception.

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents processed this record on May 24, 2017