We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modulation of Remifentanil-induced Postinfusion Hyperalgesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785863
First Posted: November 5, 2008
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Oslo
Rikshospitalet University Hospital
Information provided by:
Oslo University Hospital
  Purpose
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.

Condition Intervention Phase
Hyperalgesia, Secondary Other: Placebo Drug: Remifentanil Drug: Ketorolac and remifentanil Drug: Parecoxib and remifentanil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Modulation of Remifentanil-induced Analgesia and Postinfusion Hyperalgesia by Parecoxib or Ketorolac in Humans

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi. [ Time Frame: during the study ]

Secondary Outcome Measures:
  • HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi. [ Time Frame: During the study ]

Enrollment: 16
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo IV before placebo infusion
Active Comparator: Remifentanil Drug: Remifentanil
placebo IV and remifentanil infusion
Other Name: Ultiva
Active Comparator: Ketorolac and remifentanil Drug: Ketorolac and remifentanil
Ketorolac IV and remifentanil infusion
Other Name: Toradol
Active Comparator: Parecoxib and remifentanil Drug: Parecoxib and remifentanil
Parecoxib IV and remifentanil infusion
Other Name: Dynastat

Detailed Description:

Remifentanil is an fast acting opioid which has become very popular to use during surgery.

There are studies, both experimental 1-3 and clinical 4;5, which indicate that remifentanil after end of infusion trigger enhanced pain experience and enhanced opioid consumption postoperatively.

Therefore it is important to look at possibilities to block this enhanced pain experience (opioid induced hyperalgesia - OIH). Ketamin has demonstrated to block this effect 5;6 through the NMDA receptor. Unfortunately ketamin has some seriously side-effects like hallucinations, and is therefore not suitable in ordenary clinical use.

Recently, it has been demonstrated that parecoxib (a COX-2 inhibitor) can prevent remifentanil-induced postinfusion hyperalgesia in a study on healthy volunteers.7 COX-2 inhibitors have some disadvantages because of the longterm adverse effects like cardiac arrest. Therefore it would be of interest to look at a COX-1 preferring NSAID, like ketorolac, to see if also non-selective NSAIDs can partly block remifentanil-induced postinfusion hyperalgesia.

To investigate this and to provoke pain and secondary hyperalgesia we use an intradermal electrical pain model which is well established.1;7-9 Detailed description of this model look at reference 7. H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Allergy to the drugs used in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785863


Locations
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Rikshospitalet University Hospital
Investigators
Principal Investigator: Harald Lenz, MD Ullevaal University Hospital
Study Director: Johan Raeder, Prof.,MD,PhD Ullevaal University Hospital
Study Director: Audun Stubhaug, Prof.,MD,PhD Rikshospitalet University Hospital
  More Information

Responsible Party: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00785863     History of Changes
Other Study ID Numbers: 2008-000904-10
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: July 1, 2011
Last Verified: November 2008

Keywords provided by Oslo University Hospital:
hyperalgesia
remifentanil
ketorolac
parecoxib
COX-1 inhibitor
COX-2 inhibitor

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Remifentanil
Ketorolac
Ketorolac Tromethamine
Parecoxib
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors