The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
Primary Purpose
Hyperalgesia
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Remifentanil
Midazolam
Sponsored by
About this trial
This is an interventional basic science trial for Hyperalgesia focused on measuring Sunburn, Remifentanil, Hyperalgesia
Eligibility Criteria
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
Sites / Locations
- Department of Anaesthesia, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remifentanil
Midazolam
Arm Description
Remifentanil Infusion
Active Placebo
Outcomes
Primary Outcome Measures
Measure: Area of pin prick hyperalgesia
Secondary Outcome Measures
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
Heat pain threshold within the area of mechanical hyperalgesia
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Adverse effects
Full Information
NCT ID
NCT01015482
First Posted
November 17, 2009
Last Updated
November 17, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01015482
Brief Title
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
Official Title
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
Sunburn, Remifentanil, Hyperalgesia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil
Arm Type
Experimental
Arm Description
Remifentanil Infusion
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Active Placebo
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Remifentanil Infusion
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
Midazolam Infusion
Primary Outcome Measure Information:
Title
Measure: Area of pin prick hyperalgesia
Time Frame
0-6h
Secondary Outcome Measure Information:
Title
Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)
Time Frame
0-6h
Title
Heat pain threshold within the area of mechanical hyperalgesia
Time Frame
0-6h
Title
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Time Frame
0-6h
Title
Adverse effects
Time Frame
30 and 59 min after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Chiari, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesia, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael H Andreae, MD
Phone
+436769677181
Email
michael@andreae.org
First Name & Middle Initial & Last Name & Degree
Brigitte E Scheffold
Phone
+43140400
Ext
2221
Email
brigitte.scheffold@web.de
First Name & Middle Initial & Last Name & Degree
Astrid Chiari, MD
First Name & Middle Initial & Last Name & Degree
Burkhard Gustorff, MD
First Name & Middle Initial & Last Name & Degree
Michael H Andreae, MD
First Name & Middle Initial & Last Name & Degree
Brigitte E Scheffold
First Name & Middle Initial & Last Name & Degree
Jürgen Sandkühler, MD PHD
First Name & Middle Initial & Last Name & Degree
Ruth Drdla, PHD
12. IPD Sharing Statement
Learn more about this trial
The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun)
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