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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

About this trial

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

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

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

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

michael@andreae.org

First Name & Middle Initial & Last Name or Official Title & Degree

Bernd Schudermaier, M.Pharm

Phone

+43140400

Ext

6428

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

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