Relationship Between Cognitive Function and Pain

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.

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Key information

Conditions

Cognitive Ability, General

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultiva (remifentanil) or placebo

Drug

0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min

Other names: Ultiva (remifentanil)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Mech-Sense

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 17, 2011
Registry last updated: Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed