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| Name | Class |
|---|---|
| Akron Molecules AG | INDUSTRY |
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This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Experimental | Drug: Midazolam (experimental) |
|
| Isotonic saline | Placebo Comparator | Drug: Isotonic saline (placebo) |
|
| Fentanyl | Active Comparator | Drug: Fentanyl (active comparator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug |
|
| |
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain ratings (0-100) to a suprathreshold heat pain stimulus | 3.5 Minutes after end of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain ratings to a suprathreshold electrical pain stimulus | 3.5 Minutes after end of infusion | |
| Increase of pressure pain thresholds (kPa) | Up until 23 Minutes after end of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burkhard Gustorff, Prof.Dr. | Wilhelminenspital Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schmerzdiagnostik / Clinical Research Unit | Vienna | State of Vienna | 1190 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36877132 | Derived | Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| Isotonic saline | Drug |
|
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |