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Completed

NCT Number: NCT02252458

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, University of Basel Hospital

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Primary outcomes

  1. 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

  1. Pain as measured by the nonverbal rating scale

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

  2. cold pressor pain

    Time frame: at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion

  3. 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

  4. pupillary dilation response

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: FentaOIH-V

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2014
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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