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The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers

NCT ID: NCT00886106

Last Updated: 2009-11-18

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.

Detailed Description

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Conditions

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Hyperalgesia

Keywords

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Capsaicin Remifentanil Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Remifentanil

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Remifentanil (Ultiva®; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to circa 0.7 µg kg-1 min-1

2

Midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied intravenously as active placebo at a dose of 15 µg kg-1 min-1 over 5 minutes to mimic typical central nervous side effects of remifentanil

Interventions

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Remifentanil

Remifentanil (Ultiva®; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to circa 0.7 µg kg-1 min-1

Intervention Type DRUG

Midazolam

Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied intravenously as active placebo at a dose of 15 µg kg-1 min-1 over 5 minutes to mimic typical central nervous side effects of remifentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women, aged between 19 and 40 years
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding
* Regular consumption of very spicy (capsaicin containing) food
* Allergy against any medication used in the study protocol
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna, Dept. Anaesthesia

Principal Investigators

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Burkhard Gustorff, MD

Role: STUDY_CHAIR

Medical University of Vienna

Locations

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Department of Anaesthesia, Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Michael Andreae, MD

Role: CONTACT

Phone: +436769677181

Email: [email protected]

Stephan Stellnberger, MD

Role: CONTACT

Phone: +436507333189

Email: [email protected]

Facility Contacts

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Michael Andreae, MD

Role: primary

Stephan Stellnberger, MD

Role: backup

Other Identifiers

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RemiAnes 1

Identifier Type: -

Identifier Source: org_study_id