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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

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

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

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

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

michael@andreae.org

First Name & Middle Initial & Last Name & Degree

Brigitte E Scheffold

Phone

+43140400

Ext

2221

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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