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

NCT ID: NCT00853333

Last Updated: 2014-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Propofol

Administration via an IV

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

Midazolam

Administration via an IV

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

Dexmedetomidine

Administration via an IV

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

Interventions

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dexmedetomidine

Intervention Type DRUG

midazolam

Intervention Type DRUG

propofol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Society of Regional Anesthesia

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Froelich

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael A Froelich, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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

Reference Type RESULT
PMID: 23314164 (View on PubMed)

Other Identifiers

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F081016014

Identifier Type: -

Identifier Source: org_study_id

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