Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
Overview
- Phase
- Not Applicable
- Intervention
- Fentanyl
- Conditions
- Healthy
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Fentanyl high dose
Fentanyl 10mcg/kg of bodyweight
Intervention: Fentanyl
Fentanyl low dose
Fentanyl 1mcg/kg of bodyweight
Intervention: Fentanyl
Outcomes
Primary Outcomes
COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
Time Frame: 4.5 to 6.5h after begin of fentanyl infusion
Secondary Outcomes
- 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)