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The Effect of Remifentanil on the Reversal of Established Capsaicin-Induced Hyperalgesia in Human Volunteers (RemiCaps2)
This study is currently recruiting participants.
Verified by Medical University of Vienna, December 2008
Sponsored by: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00789386
  Purpose

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 a previously unrecognized effect of opioids, the reversal of these long term changes.

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


Condition Intervention Phase
Hyperalgesia
Drug: Remifentanil
Drug: Midazolam
Phase IV

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Remifentanil Remifentanil hydrochloride Capsaicin
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: The Effect of Remifentanil on the Reversal of Established Capsaicin-Induced Hyperalgesia in Human Volunteers

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Area of pin prick hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN) [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Pain immediately after injection [ Time Frame: 0-15 minutes ] [ Designated as safety issue: No ]
  • Heat pain threshold within the area of mechanical hyperalgesia [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 10 and 30 min after infusion of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Remifentanil: Experimental Drug: Remifentanil
Remifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes.
Midazolam: Placebo Comparator
Active Placebo
Drug: Midazolam
Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789386

Contacts
Contact: Michael H Andreae, MD +436769677181 michael@andreae.org
Contact: Bernd Schudermaier, M.Pharm +43140400 ext 6428 bernd.schmudermaier@meduniwien.ac.at

Locations
Austria
Department of Anaesthesia, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Principal Investigator: Burkhard Gustorff, MD            
Sub-Investigator: Michael H Andreae, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Burkhard Gustorff, MD Medical University of Vienna
  More Information

Study Group Webpage  This link exits the ClinicalTrials.gov site

Responsible Party: Vienna Human Pain Research Group, Department of Anaesthesia, Medical University of Vienna ( Professor Burkhard Gustorff )
Study ID Numbers: VHPRG-RemiCaps2, LS07-040
Study First Received: November 10, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00789386  
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
Capsaicin
Remifentanil
Hyperalgesia

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Remifentanil
Neurologic Manifestations
Midazolam
Capsaicin
Hyperalgesia

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Antipruritics
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Dermatologic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009