Auditory Evoked Potentials and Experimental Pain

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. Identifier: NCT00745472
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Information provided by:
Odense University Hospital

Brief Summary:
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 or disease

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.

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: The Amplitude of Auditory Evoked Potentials and the Intensity of Experimental Pain Stimulation in Healthy Volunteers
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008


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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Healthy
  • Age 20 - 40 years old

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 identifier (NCT number): NCT00745472

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

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

Keywords provided by Odense University Hospital:
experimental pain
healthy volunteers