The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)

NCT01015482 | Unknown Phase 4

• 1 other identifier: HighDose RemiSun
• 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. UV-B irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after UV-B irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.

Conditions

Hyperalgesia

Keywords

Sunburn; Remifentanil; Hyperalgesia

Outcome Measures

Primary Outcomes (1)

• Measure: Area of pin prick hyperalgesia

  0-6h

Secondary Outcomes (4)

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

  0-6h

• Heat pain threshold within the area of mechanical hyperalgesia

  0-6h

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

  0-6h

• Adverse effects

  30 and 59 min after start of treatment

Study Arms (2)

Remifentanil

EXPERIMENTAL

Remifentanil Infusion

Drug: Remifentanil

Midazolam

ACTIVE COMPARATOR

Active Placebo

Drug: Midazolam

Interventions

Remifentanil DRUG

Remifentanil Infusion

Also known as: Ultiva

Remifentanil

Midazolam DRUG

Midazolam Infusion

Also known as: Dormicum

Midazolam

Eligibility Criteria

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

You may qualify if:

• 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
• UV sensitive skin conditions, like Xeroderma pigmentosa

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; Sunburn

Interventions

Remifentanil; Midazolam

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries

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

• Astrid Chiari, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

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: November 17, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 18, 2009

Record last verified: 2009-11

Locations

AU (1)