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

NCT00853333 | Completed Results DMC

• 1 other identifier: F081016014
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Pain; Propofol; Dexmedetomidine; Midazolam; Effects of sedation on pain perception.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Propofol

ACTIVE COMPARATOR

Administration via an IV

Drug: propofol

Midazolam

ACTIVE COMPARATOR

Administration via an IV

Drug: midazolam

Dexmedetomidine

ACTIVE COMPARATOR

Administration via an IV

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

Dexmedetomidine

midazolam DRUG

Midazolam

propofol DRUG

Propofol

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• years or older able to follow study instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Society of Regional Anesthesia: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

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

  PMID: 23314164 RESULT

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Midazolam; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Michael Froelich
• Organization: University of Alabama at Birmigham

froelich@uab.edu

(205)975-0145

Study Officials

• Michael A Froelich, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-06

Locations

US (1)