The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers (RemiCaps2)
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 Capsaicin, 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
Sites / Locations
- Department of Anaesthesia, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Remifentanil
Midazolam
Arm Description
Active Placebo
Outcomes
Primary Outcome Measures
Area of pin prick hyperalgesia
Secondary Outcome Measures
Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)
Pain immediately after injection
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
NCT00789386
First Posted
November 10, 2008
Last Updated
May 20, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00789386
Brief Title
The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
Acronym
RemiCaps2
Official Title
The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
Capsaicin, Remifentanil, Hyperalgesia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil
Arm Type
Experimental
Arm Title
Midazolam
Arm Type
Placebo Comparator
Arm Description
Active Placebo
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Remifentanil (Ultiva ®; Glaxo-Smith-Kline; Vienna, Austria) at an initial dose of 0.24 µg kg-1 min-1 will be applied iv during 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied iv as active placebo at a dose of 7.5 µg.kg-1.min-1 over 10 minutes to mimic typical central nervous side effects of remifentanil.
Primary Outcome Measure Information:
Title
Area of pin prick hyperalgesia
Time Frame
0-6 hours
Secondary Outcome Measure Information:
Title
Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)
Time Frame
0-6 hours
Title
Pain immediately after injection
Time Frame
0-15 minutes
Title
Heat pain threshold within the area of mechanical hyperalgesia
Time Frame
0-6 hours
Title
Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
Time Frame
0-6 hours
Title
Adverse effects
Time Frame
10 and 30 min after infusion of study medication
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael H Andreae, MD
Phone
+436769677181
Email
michael@andreae.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bernd Schudermaier, M.Pharm
Phone
+43140400
Ext
6428
Email
bernd.schmudermaier@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burkhard Gustorff, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Chair
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
Astrid Chiari, MD
First Name & Middle Initial & Last Name & Degree
Burkhard Gustorff, MD
First Name & Middle Initial & Last Name & Degree
Bernd Schmudermaier, MSc. Pharm
First Name & Middle Initial & Last Name & Degree
Martin Schmudermaier, MD
First Name & Middle Initial & Last Name & Degree
Michael H Andreae, MD
First Name & Middle Initial & Last Name & Degree
Hanna Opelt, MD
First Name & Middle Initial & Last Name & Degree
Stephan Stellnberger, MD
First Name & Middle Initial & Last Name & Degree
Juergen Sandkuehler, MD, PHD
First Name & Middle Initial & Last Name & Degree
Ruth Drdla, PHD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
We'll reach out to this number within 24 hrs