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

Hyperalgesia Clinical Trial

— RemiAnes 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886106
• Other study ID #: RemiAnes 1
• Status: Recruiting
• Phase: Phase 4
• First received: April 21, 2009
• Last updated: November 17, 2009
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2009
• Source: Medical University of Vienna
• Contact: Michael Andreae, MD
• Phone: +436769677181
• Email: michael[@]andreae.org
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• 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: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hyperalgesia

Intervention

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
• 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

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	Pain immediately after injection		0-15 min	No
Secondary	Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)		0-6 hours	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		30 and 59 min after infusion of study medication	Yes

External Links

•   Vienna Human Pain Research Group