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The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.
The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl high dose | Experimental | Fentanyl 10mcg/kg of bodyweight |
|
| Fentanyl low dose | Active Comparator | Fentanyl 1mcg/kg of bodyweight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below. | 4.5 to 6.5h after begin of fentanyl infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as measured by the nonverbal rating scale | 0-2h after begin of fentanyl infusion at 15 min intervals | |
| cold pressor pain | at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilhelm Ruppen, PD Dr., MD | University Hospital Basel, Dep. of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, University of Basel Hospital | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28106611 | Derived | Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol) |
| -15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion |
| pupillary dilation response | baseline and at 4.5h after begin of infusion |