Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Fentanyl

• Registration Number: NCT02252458
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-09-30
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fentanyl high dose	Fentanyl	Fentanyl 10mcg/kg of bodyweight
Fentanyl low dose	Fentanyl	Fentanyl 1mcg/kg of bodyweight

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesia, University of Basel Hospital; 🇨🇭 Basel, Switzerland