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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: midazolam; Drug: dexmedetomidine; Drug: propofol

• Registration Number: NCT00853333
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-08-23
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Results First Posted: 2014-06-26
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	midazolam	Administration via an IV
Dexmedetomidine	dexmedetomidine	Administration via an IV
Propofol	propofol	Administration via an IV

Primary Outcome Measures

Name	Time	Method
Pain Rating Change	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States