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The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers

The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00811837
Acronym
RemiSun 1
Enrollment
24
Registered
2008-12-19
Start date
2009-01-31
Completion date
2009-09-30
Last updated
2009-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperalgesia

Keywords

Sunburn, Remifentanil, Hyperalgesia

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.

Interventions

DRUGMidazolam

Intravenous infusion

DRUGRemifentanil

Intravenous infusion

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes

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 * UV sensitive skin conditions, like Xeroderma pigmentosa

Design outcomes

Primary

MeasureTime frame
Area of pin prick hyperalgesia0-6 hours

Secondary

MeasureTime frame
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)0-6 hours
Heat pain threshold within the area of mechanical hyperalgesia0-6 hours
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush0-6 hours
Adverse effects30 and 59 min after start of treatment

Countries

Austria

Contacts

Primary ContactMichael H Andreae, MD
michael@andreae.org+436769677181
Backup ContactBrigitte E Scheffold, MD
brigitte.scheffold@meduni.wien.ac.at+4340400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026