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

Healthy Clinical Trial

— FentaOIH-V  

Official title:

Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252458
• Other study ID #: 2014-054
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: January 8, 2015
• Start date: August 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy
• Hyperalgesia

Intervention

Drug:
• Fentanyl

Locations

Country	Name	City	State
Switzerland	Department of Anesthesia, University of Basel Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain as measured by the nonverbal rating scale		0-2h after begin of fentanyl infusion at 15 min intervals	No
Secondary	cold pressor pain		at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion	No
Secondary	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	No
Secondary	pupillary dilation response		baseline and at 4.5h after begin of infusion	No