- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00853333
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
June 24, 2014 updated by: Michael Froelich, University of Alabama at Birmingham
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propofol
Administration via an IV
|
|
Active Comparator: Midazolam
Administration via an IV
|
|
Active Comparator: Dexmedetomidine
Administration via an IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Sedation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael A Froelich, M.D., University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 26, 2009
First Submitted That Met QC Criteria
February 27, 2009
First Posted (Estimate)
March 2, 2009
Study Record Updates
Last Update Posted (Estimate)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- F081016014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on dexmedetomidine
-
Cairo UniversityUnknownSpinal Anesthesia DurationEgypt
-
Guangzhou Women and Children's Medical CenterCompletedAmbulatory Surgical ProceduresChina
-
The First Affiliated Hospital with Nanjing Medical...CompletedPostoperative Pain | Breast Feeding | Analgesia ObstetricalChina
-
Seoul National University Bundang HospitalCompleted
-
Guangzhou General Hospital of Guangzhou Military...CompletedPharmacodynamic InteractionChina
-
University Hospital DubravaRecruitingAortic Valve Stenosis | Systemic Inflammatory ResponseCroatia
-
Guangzhou General Hospital of Guangzhou Military...Completed
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknownArteriovenous MalformationChina
-
Guangzhou General Hospital of Guangzhou Military...UnknownCombined Spinal-epidural AnesthesiaChina
-
National Cancer Institute, EgyptCompleted