Relationship Between Cognitive Function and Pain

NCT01375348 | Completed Phase 3 DMC

• 1 other identifier: Kogprem
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Ability, General

Keywords

Cognitive function; Experimental pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

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

Placebo infusion

PLACEBO COMPARATOR

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

Interventions

Ultiva (remifentanil) or placebo DRUG

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

Also known as: Ultiva (remifentanil)

Placebo infusion; Remifentanil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Mech-Sense: collaborator

Study Sites (1)

Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Graversen C, Malver LP, Kurita GP, Staahl C, Christrup LL, Sjogren P, Drewes AM. Altered frequency distribution in the electroencephalogram is correlated to the analgesic effect of remifentanil. Basic Clin Pharmacol Toxicol. 2015 May;116(5):414-22. doi: 10.1111/bcpt.12330. Epub 2014 Oct 21.

  PMID: 25250670 DERIVED

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Asbjørn M Drewes, Professor

  Mech-Sense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

DK (1)