Relationship Between Cognitive Function and Pain

Cognitive Ability, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375348
• Other study ID #: Kogprem
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2011
• Last updated: February 13, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cognitive Ability, General

Intervention

Drug:
• Ultiva (remifentanil) or placebo
0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min

Locations

Country	Name	City	State
Denmark	Mech-Sense, Department of Gastroenterology, Aalborg Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Mech-Sense

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	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	No