Modulation of Remifentanil-induced Postinfusion Hyperalgesia

NCT00785863 | Completed Phase 4

• 1 other identifier: 2008-000904-10
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1 and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this experimental pain model.

Conditions

Hyperalgesia, Secondary

Keywords

hyperalgesia; remifentanil; ketorolac; parecoxib; COX-1 inhibitor; COX-2 inhibitor

Outcome Measures

Primary Outcomes (1)

• H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi.

  during the study

Secondary Outcomes (1)

• HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

  During the study

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

Ketorolac and remifentanil

ACTIVE COMPARATOR

Drug: Ketorolac and remifentanil

Parecoxib and remifentanil

ACTIVE COMPARATOR

Drug: Parecoxib and remifentanil

Interventions

Placebo OTHER

Placebo IV before placebo infusion

Placebo

Remifentanil DRUG

placebo IV and remifentanil infusion

Also known as: Ultiva

Remifentanil

Ketorolac and remifentanil DRUG

Ketorolac IV and remifentanil infusion

Also known as: Toradol

Ketorolac and remifentanil

Parecoxib and remifentanil DRUG

Parecoxib IV and remifentanil infusion

Also known as: Dynastat

Parecoxib and remifentanil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• Allergy to the drugs used in the study

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• University of Oslo: collaborator
• Rikshospitalet University Hospital: collaborator

Study Sites (1)

Ullevaal University Hospital

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

Remifentanil; Ketorolac; Ketorolac Tromethamine; parecoxib

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Harald Lenz, MD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

• Johan Raeder, Prof.,MD,PhD

  Ullevaal University Hospital

  STUDY DIRECTOR

• Audun Stubhaug, Prof.,MD,PhD

  Rikshospitalet University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 1, 2011

Record last verified: 2008-11

Locations

NO (1)