Auditory Evoked Potentials and Experimental Pain

Pain Clinical Trial

Official title:

The Amplitude of Auditory Evoked Potentials and the Intensity of Experimental Pain Stimulation in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745472
• Other study ID #: 30071993
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: September 2, 2008
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: September 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy

• Age 20 - 40 years old

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS and amplitude of AEP		before, during and after experimental pain	No
Secondary	reproducibility		after an hour	No