Status:
COMPLETED
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
MALE
18+ years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- Healthy (ASA I-II) male volunteers
- Age \> 18 years
- BMI 18 - 25 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02252458
Start Date
August 1 2014
End Date
January 1 2015
Last Update
January 9 2015
Active Locations (1)
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1
Department of Anesthesia, University of Basel Hospital
Basel, Switzerland, 4031