Relationship Between Cognitive Function and Pain

NCT ID: NCT01375348

Last Updated: 2012-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Cognitive Ability, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remifentanil

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

Group Type ACTIVE_COMPARATOR

Ultiva (remifentanil) or placebo

Intervention Type DRUG

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

Placebo infusion

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

Group Type PLACEBO_COMPARATOR

Ultiva (remifentanil) or placebo

Intervention Type DRUG

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

Interventions

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Ultiva (remifentanil) or placebo

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

Intervention Type DRUG

Other Intervention Names

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Ultiva (remifentanil)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mech-Sense

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asbjørn M Drewes, Professor

Role: PRINCIPAL_INVESTIGATOR

Mech-Sense

Locations

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Mech-Sense, Department of Gastroenterology, Aalborg Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25250670 (View on PubMed)

Other Identifiers

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Kogprem

Identifier Type: -

Identifier Source: org_study_id

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