Relationship Between Cognitive Function and Pain

This study has been completed.
Sponsor:
Collaborator:
Mech-Sense
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01375348
First received: June 15, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Cognitive Ability, General
Drug: Ultiva (remifentanil) or placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Cognitive Function in Healthy Volunteers Exposed to Acute Pain Before and After Administration of Remifentanil

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: 3 experiments each lasting for about 4-6hours - total duration of study is around 8-9month ] [ Designated as safety issue: No ]
    Investigate the relationship between cognitive function and pain and treatment with remifentanil


Enrollment: 23
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Ultiva (remifentanil)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375348

Locations
Denmark
Mech-Sense, Department of Gastroenterology, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Mech-Sense
Investigators
Principal Investigator: Asbjørn M Drewes, Professor Mech-Sense
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01375348     History of Changes
Other Study ID Numbers: Kogprem
Study First Received: June 15, 2011
Last Updated: February 13, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Cognitive function
Experimental pain

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 27, 2014