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

NCT00886106 | Unknown Phase 4

• 1 other identifier: RemiAnes 1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperalgesia

Keywords

Capsaicin; Remifentanil; Hyperalgesia

Outcome Measures

Primary Outcomes (1)

• Area of pin prick hyperalgesia

  0-6 hours

Secondary Outcomes (5)

• Pain immediately after injection

  0-15 min

• Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)

  0-6 hours

• Heat pain threshold within the area of mechanical hyperalgesia

  0-6 hours

• Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush

  0-6 hours

• Adverse effects

  30 and 59 min after infusion of study medication

Study Arms (2)

1

EXPERIMENTAL

Remifentanil

Drug: Remifentanil

2

ACTIVE COMPARATOR

Midazolam

Drug: Midazolam

Interventions

Remifentanil 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

1

Midazolam 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

2

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Anaesthesia, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Hyperalgesia

Interventions

Remifentanil; Midazolam

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Burkhard Gustorff, MD

  Medical University of Vienna

  STUDY CHAIR

Central Study Contacts

Michael Andreae, MD

CONTACT

+436769677181; michael@andreae.org

Stephan Stellnberger, MD

CONTACT

+436507333189; stephan.stellnberger@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: November 18, 2009

Record last verified: 2009-11

Locations

AU (1)