Healthy
Conditions
Keywords
Opioid induced hyperalgesia, Fentanyl
Brief summary
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.
Interventions
DRUGFentanyl
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy (ASA I-II) male volunteers * Age \> 18 years * BMI 18 - 25 kg/m2
Exclusion criteria
* Volunteers unable to give written informed consent * Known drug allergies or intolerance to fentanyl * Known drug allergies or intolerance to morphine and other opiates * Recreational drug addiction or abuse * Opiate use in the last month * Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month * History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease * Patients with renal failure (clearance \< 30 ml/min) * obstructive sleep apnea syndrome (OSAS) * Indication for Rapid Sequence Induction * Patients not understanding German, French, Italian or English
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed