Relationship Between Cognitive Function and Pain

February 13, 2012 updated by: University of Aarhus

Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil

Patients with chronic pain can experience considerable changes in their cognitive function such as forgetfulness, increased absentmindedness, confusion etc. Opioids (e.g. morphine and morphine-like analgesics) are often used in treatment of acute and chronic pain and can lead to worsening of the cognitive function. The interaction between pain, treatment and cognitive function is very complex and is far from understood.

The hypothesis of the present study is that by use of experimental pain in healthy volunteers it will be possible to elucidate the interaction between pain, treatment and cognitive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men aged 18-65 years
  • Normal vision and hearing
  • No disease associated with cognitive dysfunction

Exclusion Criteria:

  • Allergic to remifentanil or patches
  • Any use of pain killers or alcohol 48hours before study start
  • Current participation in other clinical studies or participation within the last 14days before study start
  • Prescribed medication
  • Risk of developing
  • Previously alcohol- or drug addict
  • MMSE score < 26

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remifentanil

Investigate the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:

  • tonic muscle pain induced by the tourniquet pain model
  • cognitive tests
  • recording of brain activity by use of 64 channel cap
Drug: Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Other Names:
  • Ultiva (remifentanil)
Placebo Comparator: Placebo infusion

To blind the study and use as comparator in the investigation of the effect of remifentanil on cognitive function in healthy volunteers by use of experimental pain models:

  • tonic muscle induced pain by the tourniquet pain model
  • cognitive tests
  • brain activity by use of a 64 channel cap
Drug: Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
Other Names:
  • Ultiva (remifentanil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month
Investigate the relationship between cognitive function and pain and treatment with remifentanil
3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Mech-Sense

Investigators

  • Principal Investigator: Asbjørn M Drewes, Professor, Mech-Sense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kogprem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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