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OpenTrials
Completed

NCT Number: NCT00853333

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

midazolam

Drug

Propofol

Drug

Primary outcomes

  1. Pain Rating Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Society of Regional Anesthesia

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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