Relationship Between Cognitive Function and Pain

University of Aarhus

Status and phase: Completed; Phase 3

Conditions: Cognitive Ability, General

Treatments: Drug: Ultiva (remifentanil) or placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01375348

Kogprem

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 2 patient groups, including a placebo group

Remifentanil

Active Comparator group

Description:

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

Treatment:

Drug: Ultiva (remifentanil) or placebo

Placebo infusion

Placebo Comparator group

Description:

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

Treatment:

Drug: Ultiva (remifentanil) or placebo