The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers (RemiAnes 1)

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: Hyperalgesia

Treatments: Drug: Midazolam; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00886106

RemiAnes 1

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

1

Experimental group

Description:

Remifentanil

Treatment:

Drug: Remifentanil

2

Active Comparator group

Description:

Midazolam

Treatment:

Drug: Midazolam