The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers

NCT ID: NCT00789386

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Remifentanil

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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

Active Placebo

Group Type: PLACEBO_COMPARATOR

Midazolam

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Vienna Human Pain Research Group, Department of Anaesthesia, Medical University of Vienna

Principal Investigators

Burkhard Gustorff, MD

Role: STUDY_CHAIR

Medical University of Vienna

Locations

Department of Anaesthesia, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Michael H Andreae, MD

Role: CONTACT

michael@andreae.org

+436769677181

Bernd Schudermaier, M.Pharm

Role: CONTACT

bernd.schmudermaier@meduniwien.ac.at

+43140400 ext. 6428

Other Identifiers

LS07-040

Identifier Type: -

Identifier Source: secondary_id

VHPRG-RemiCaps2

Identifier Type: -

Identifier Source: org_study_id