Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? (FentaOIH-V)

January 8, 2015 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Anesthesia, University of Basel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl high dose
Fentanyl 10mcg/kg of bodyweight
Drug: Fentanyl
Active Comparator: Fentanyl low dose
Fentanyl 1mcg/kg of bodyweight
Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4.5 to 6.5h after begin of fentanyl infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain as measured by the nonverbal rating scale
Time Frame: 0-2h after begin of fentanyl infusion at 15 min intervals
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
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
-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
baseline and at 4.5h after begin of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Wilhelm Ruppen, PD Dr., MD, University Hospital Basel, Dep. of Anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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