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Clinical Trials/NCT00853333
NCT00853333
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country86 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
propofol
Conditions
Pain
Sponsor
University of Alabama at Birmingham
Enrollment
86
Locations
1
Primary Endpoint
Pain Rating Change
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
January 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Froelich

M.D.

University of Alabama at Birmingham

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

Arms & Interventions

Propofol

Administration via an IV

Intervention: propofol

Midazolam

Administration via an IV

Intervention: midazolam

Dexmedetomidine

Administration via an IV

Intervention: dexmedetomidine

Outcomes

Primary Outcomes

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.

Study Sites (1)

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