Relationship Between Cognitive Function and Pain

Phase 3

Completed

• Conditions: Cognitive Ability, General
• Interventions: Drug: Ultiva (remifentanil) or placebo

• Registration Number: NCT01375348
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo infusion	Ultiva (remifentanil) or placebo	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
Remifentanil	Ultiva (remifentanil) or placebo	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

Primary Outcome Measures

Name	Time	Method
Cognitive function	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

Trial Locations

Locations (1)

Mech-Sense, Department of Gastroenterology, Aalborg Hospital; 🇩🇰 Aalborg, Denmark