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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers

NCT00714558

Biological Availability

COMPLETED PHASE1

Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

NCT00647127

Pain

COMPLETED PHASE3

Nebulized Fentanyl in Healthy Volunteers

NCT06281951

Analgesia Emergencies

RECRUITING PHASE1

Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting

NCT02914678

Acute Pain

COMPLETED NA

A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant

NCT00650182

Chronic Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fentanyl high dose

Fentanyl 10mcg/kg of bodyweight

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Fentanyl low dose

Fentanyl 1mcg/kg of bodyweight

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fentanyl

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes