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

University Hospital, Basel, Switzerland21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

FentanylDRUG

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesia, University of Basel Hospital

Basel, Switzerland

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

Time frame: 0-2h after begin of fentanyl infusion at 15 min intervals

cold pressor pain

Time frame: 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)

Time frame: -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

Time frame: baseline and at 4.5h after begin of infusion

Data from ClinicalTrials.gov

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