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Status unknownNCT01015482Updated Nov 18, 2009

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

A Phase 4 interventional study of Remifentanil and Midazolam in Hyperalgesia, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-18.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperalgesia

Keywords

  • Sunburn
  • Remifentanil
  • Hyperalgesia
03

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Remifentanil

    Remifentanil Infusion

    Drug: Remifentanil

  • Active comparator
    Midazolam

    Active Placebo

    Drug: Midazolam

Interventions

  • DrugRemifentanil

    Remifentanil Infusion

    Also known as: Ultiva

  • DrugMidazolam

    Midazolam Infusion

    Also known as: Dormicum

05

What researchers measure

Primary outcomes

  1. Measure: Area of pin prick hyperalgesia

    Time frame: 0-6h

Secondary outcomes

  1. Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)

    Time frame: 0-6h

  2. Heat pain threshold within the area of mechanical hyperalgesia

    Time frame: 0-6h

  3. Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush

    Time frame: 0-6h

  4. Adverse effects

    Time frame: 30 and 59 min after start of treatment

06

Study locations

1 of 1 sites recruiting
  • Department of Anaesthesia, Medical University of Vienna
    Vienna, 1090, Austria
    • Michael H Andreae, MD · Contact · michael@andreae.org · +436769677181
    • Brigitte E Scheffold · Contact · brigitte.scheffold@web.de · +43140400
    • Astrid Chiari, MD · Principal investigator
    • Burkhard Gustorff, MD · Sub investigator
    • Michael H Andreae, MD · Sub investigator
    • Brigitte E Scheffold · Sub investigator
    • Jürgen Sandkühler, MD PHD · Sub investigator
    • Ruth Drdla, PHD · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT01015482
Lead sponsor
Medical University of Vienna
First posted
Nov 18, 2009
Start date
Nov 2009
Primary completion
Mar 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Nov 18, 2009

Study contacts

Astrid Chiari, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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