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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Opioid induced hyperalgesia, Fentanyl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anesthesia, University of Basel Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fentanyl high dose

Fentanyl low dose

Arm Description

Fentanyl 10mcg/kg of bodyweight

Fentanyl 1mcg/kg of bodyweight

Outcomes

Primary Outcome Measures

COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.

Secondary Outcome Measures

Pain as measured by the nonverbal rating scale
cold pressor pain
Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)
pupillary dilation response

Full Information

First Posted
September 8, 2014
Last Updated
January 8, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02252458
Brief Title
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
Acronym
FentaOIH-V
Official Title
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Opioid induced hyperalgesia, Fentanyl

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl high dose
Arm Type
Experimental
Arm Description
Fentanyl 10mcg/kg of bodyweight
Arm Title
Fentanyl low dose
Arm Type
Active Comparator
Arm Description
Fentanyl 1mcg/kg of bodyweight
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Pain as measured by the nonverbal rating scale
Time Frame
0-2h after begin of fentanyl infusion at 15 min intervals
Title
cold pressor pain
Time Frame
at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion
Title
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
Title
pupillary dilation response
Time Frame
baseline and at 4.5h after begin of infusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm Ruppen, PD Dr., MD
Organizational Affiliation
University Hospital Basel, Dep. of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, University of Basel Hospital
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28106611
Citation
Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592.
Results Reference
derived

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

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