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The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (RemiSun 1)

Primary Purpose

Hyperalgesia

Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Midazolam
Remifentanil
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperalgesia focused on measuring Sunburn, Remifentanil, Hyperalgesia

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Remifentail

Midazolam

Arm Description

Remifentanil Infusion

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)
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

First Posted
December 18, 2008
Last Updated
November 17, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00811837
Brief Title
The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers
Acronym
RemiSun 1
Official Title
The Effect of Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
September 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. 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.

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
Remifentail
Arm Type
Experimental
Arm Description
Remifentanil Infusion
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Active Placebo
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
Intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Intravenous infusion
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
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
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
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
Brigitte E Scheffold, MD
Phone
+4340400
Ext
6428
Email
brigitte.scheffold@meduni.wien.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
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

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

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