A Phase 4 interventional study of Midazolam and Remifentanil in Hyperalgesia, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-18.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Basic science
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.
166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 142 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Remifentanil Infusion
Drug: Remifentanil
Active Placebo
Drug: Midazolam
Intravenous infusion
Also known as: Dormicum
Intravenous infusion
Also known as: Ultiva
Area of pin prick hyperalgesia
Time frame: 0-6 hours
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
Time frame: 0-6 hours
Heat pain threshold within the area of mechanical hyperalgesia
Time frame: 0-6 hours
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Time frame: 0-6 hours
Adverse effects
Time frame: 30 and 59 min after start of treatment
The record gives a start of Jan 2009, a primary completion of Jul 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remifentanil
Medical University of Vienna →