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

Hyperalgesia Clinical Trial

— RemiCaps2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00789386
• Other study ID #: VHPRG-RemiCaps2
• Secondary ID: LS07-040
• Status: Recruiting
• Phase: Phase 4
• First received: November 10, 2008
• Last updated: May 20, 2009
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: Medical University of Vienna
• Contact: Michael H Andreae, MD
• Phone: +436769677181
• Email: michael[@]andreae.org
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

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
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.

Locations

Country	Name	City	State
Austria	Department of Anaesthesia, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of pin prick hyperalgesia		0-6 hours	No
Secondary	Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)		0-6 hours	No
Secondary	Pain immediately after injection		0-15 minutes	No
Secondary	Heat pain threshold within the area of mechanical hyperalgesia		0-6 hours	No
Secondary	Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush		0-6 hours	No
Secondary	Adverse effects		10 and 30 min after infusion of study medication	Yes