Auditory Evoked Potentials and Experimental Pain

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00745472
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reproducibility [ Time Frame: after an hour ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00745472

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

No publications provided

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
Study First Received: September 2, 2008
Last Updated: September 2, 2008
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014