HyperalgesiaPhase 4NCT01015482
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
A Phase 4 study testing Remifentanil and Midazolam in people with Hyperalgesia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia
- What is being tested?
- Remifentanil and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination
- Drug free for 1 week prior to the study day
Who cannot join
- Regular use of medication especially analgesics
- Abuse of alcoholic beverages, drug abuse
- History of asthma
- Participation in a clinical trial in the 2 weeks preceding the study
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- Resting systolic blood pressure > 135 mmHg or diastolic blood pressure > 85 mmHg
Show all 9Show fewer
- Acute skin diseases like sunburn on the relevant areas or skin lesions
- Pregnancy or breast feeding
- UV sensitive skin conditions, like Xeroderma pigmentosa
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Anaesthesia, Medical University of Vienna
Vienna, State of Vienna, 1090
Michael H Andreae, MD, +436769677181, michael@andreae.org
Brigitte E Scheffold, +43140400 ext. 2221, brigitte.scheffold@web.de
About this study
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.
Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.
UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.
- Conditions
- Hyperalgesia
- Being tested
- Remifentanil, Midazolam
- Keywords
- Sunburn, Remifentanil, Hyperalgesia
- Medical subject headings
- Hyperalgesia, Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Remifentanil Infusion
MidazolamDrug
Also called Dormicum
Midazolam Infusion
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | Remifentanil Infusion Receives: Drug: Remifentanil |
| Midazolam | Active comparator | Active Placebo Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Area of pin prick hyperalgesia
Measured: 0-6h
Secondary outcomes (4)
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
Measured: 0-6h
Heat pain threshold within the area of mechanical hyperalgesia
Measured: 0-6h
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Measured: 0-6h
Adverse effects
Measured: 30 and 59 min after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Astrid Chiari, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015482
- Sponsor's protocol ID
- HighDose RemiSun
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
- ClinicalTrials.gov ID
- NCT01015482
- Acronym / sponsor ID
- HighDose RemiSun
- Conditions
- Hyperalgesia
- Keywords
- Sunburn, Remifentanil, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.
Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.
UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: RemifentanilRemifentanil Infusion |
| Midazolam | Active comparator | Drug: MidazolamActive Placebo |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination
- Drug free for 1 week prior to the study day
Key exclusion criteria (9 listed)
- Regular use of medication especially analgesics
- Abuse of alcoholic beverages, drug abuse
- History of asthma
- Participation in a clinical trial in the 2 weeks preceding the study
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
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 |
|---|---|---|
| RemifentanilAlso: UltivaRemifentanil Infusion | Drug | Remifentanil |
| MidazolamAlso: DormicumMidazolam Infusion | Drug | Midazolam |
Primary outcome
Measure: Area of pin prick hyperalgesia
Time frame: 0-6h
4 secondary outcomes
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
Time frame: 0-6h
Heat pain threshold within the area of mechanical hyperalgesia
Time frame: 0-6h
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Time frame: 0-6h
Adverse effects
Time frame: 30 and 59 min after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
- (Vienna Human Pain Research Group)Link provided by the sponsor.
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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.
Department of Anaesthesia, Medical University of Vienna
Vienna, Austria
Astrid Chiari, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Midazolam in people with Hyperalgesia, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Nov 2009. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Area of pin prick hyperalgesia (time frame: 0-6h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2009.