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The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers (RemiAnes 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886106
Recruitment Status : Unknown
Verified November 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : April 22, 2009
Last Update Posted : November 18, 2009
Information provided by:
Medical University of Vienna

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hyperalgesia Drug: Remifentanil Drug: Midazolam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers
Study Start Date : June 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: 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

Active Comparator: 2
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

Primary Outcome Measures :
  1. Area of pin prick hyperalgesia [ Time Frame: 0-6 hours ]

Secondary Outcome Measures :
  1. Pain immediately after injection [ Time Frame: 0-15 min ]
  2. Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6 hours ]
  3. Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6 hours ]
  4. Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6 hours ]
  5. Adverse effects [ Time Frame: 30 and 59 min after infusion of study medication ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886106

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Contact: Michael Andreae, MD +436769677181
Contact: Stephan Stellnberger, MD +436507333189

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Department of Anaesthesia, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael Andreae, MD    +436769677181   
Contact: Stephan Stellnberger, MD    +436507333189   
Principal Investigator: Astrid Chiari, MD         
Sub-Investigator: Burkhard Gustorff, MD         
Sub-Investigator: Michael H Andreae, MD         
Sub-Investigator: Stephan Stellnberger, MD         
Sub-Investigator: Hanna Opelt, MD         
Sub-Investigator: Juergen Sandkuehler, MD, PHD         
Sub-Investigator: Ruth Drdla, PHD         
Sponsors and Collaborators
Medical University of Vienna
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Study Chair: Burkhard Gustorff, MD Medical University of Vienna
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Responsible Party: Professor Burkhard Gustorff, Medical University of Vienna, Dept. Anaesthesia Identifier: NCT00886106    
Other Study ID Numbers: RemiAnes 1
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009
Keywords provided by Medical University of Vienna:
Additional relevant MeSH terms:
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Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents