PainNCT00853333
Sedation and Pain (The Effect of IV Sedation on Pain Perception)
A study testing dexmedetomidine, midazolam and propofol in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- dexmedetomidine, midazolam and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 19 years or older able to follow study instructions
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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).
Read the 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.
- Conditions
- Pain
- Being tested
- dexmedetomidine, midazolam, propofol
- Keywords
- Pain, Propofol, Dexmedetomidine, Midazolam, Effects of sedation on pain perception.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
midazolamDrug
propofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Administration via an IV Receives: Drug: propofol |
| Midazolam | Active comparator | Administration via an IV Receives: Drug: midazolam |
| Dexmedetomidine | Active comparator | Administration via an IV Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Regional Anesthesia
- Responsible party
- Principal investigator, Michael Froelich, University of Alabama at Birmingham
- Investigators
- Michael A Froelich, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853333
- Sponsor's protocol ID
- F081016014
- Status last verified
- Jun 2014
- First submitted
- 26 Feb 2009
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.
PubMed 23314164
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation and Pain (The Effect of IV Sedation on Pain Perception)
- ClinicalTrials.gov ID
- NCT00853333
- Acronym / sponsor ID
- F081016014
- Conditions
- Pain
- Keywords
- Pain, Propofol, Dexmedetomidine, Midazolam, Effects of sedation on pain perception.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Society of Regional Anesthesia
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolAdministration via an IV |
| Midazolam | Active comparator | Drug: midazolamAdministration via an IV |
| Dexmedetomidine | Active comparator | Drug: dexmedetomidineAdministration via an IV |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- 19 years or older able to follow study instructions
Key exclusion criteria (20 listed)
- Age less than 19 or greater than 40
- Pregnant female
- Obesity (BMI > or =35)
- Non-English speaking/reading participants
- Sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine | Drug | Dexmedetomidine |
| midazolam | Drug | Midazolam |
| propofol | Drug | Propofol |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23314164Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Froelich, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine, midazolam and propofol in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Rating Change (time frame: Sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00853333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.