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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853333
• Other study ID #: F081016014
• Status: Completed
• Phase: N/A
• First received: February 26, 2009
• Last updated: June 24, 2014
• Start date: November 2008
• Est. completion date: January 2012

Study information

• Verified date: June 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• dexmedetomidine

• midazolam

• propofol

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Society of Regional Anesthesia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frölich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Rating Change	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.	Sedation	No