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Auditory Evoked Potentials and Experimental Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745472
First Posted: September 3, 2008
Last Update Posted: September 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  Purpose
Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers. Electric nerve stimulation, cold and heat pain were used as pain models.

Condition
Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Amplitude of Auditory Evoked Potentials and the Intensity of Experimental Pain Stimulation in Healthy Volunteers

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • VAS and amplitude of AEP [ Time Frame: before, during and after experimental pain ]

Secondary Outcome Measures:
  • reproducibility [ Time Frame: after an hour ]

Enrollment: 20
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

During the AEP monitoring, healthy volunteers were exposed to experimental pain. At study day 1: Firstly, single electric nerve stimulation and repetitive electric nerve stimulations causing temporal pain summation. The stimulations were given at 50, 75 and 100% of the thresholds for pain tolerance and temporal pain summation. Secondly, the volunteers were exposed to cold pain by use of two different Cold Pressor Tests (CPT) with water temperatures at 8 and 1 Celsius. All measurements were repeated after an hour to test reproducibility.

At study day 2: Brief Thermal Stimulation were used with two different temperatures and duration.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers
Criteria

Inclusion Criteria:

  • Healthy
  • Age 20 - 40 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745472


Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Thomas P Enggaard, MD Odense University Hospital
  More Information

Responsible Party: Thomas P. Enggaard MD, PHD, Department of Anaesthesiology, Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00745472     History of Changes
Other Study ID Numbers: 30071993
First Submitted: September 2, 2008
First Posted: September 3, 2008
Last Update Posted: September 3, 2008
Last Verified: September 2008

Keywords provided by Odense University Hospital:
AEP
experimental pain
healthy volunteers