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| Sponsors and Collaborators: |
Ullevaal University Hospital University of Oslo Rikshospitalet University Hospital |
|---|---|
| Information provided by: | Ullevaal University Hospital |
| ClinicalTrials.gov Identifier: | NCT00785863 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Modulation of Remifentanil-Induced Analgesia and Postinfusion Hyperalgesia by Parecoxib or Ketorolac in Humans |
| Estimated Enrollment: | 16 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo: Placebo Comparator |
Other: Placebo
Placebo IV before placebo infusion
|
| Remifentanil: Active Comparator |
Drug: Remifentanil
placebo IV and remifentanil infusion
|
| Ketorolac and remifentanil: Active Comparator |
Drug: Ketorolac and remifentanil
Ketorolac IV and remifentanil infusion
|
| Parecoxib and remifentanil: Active Comparator |
Drug: Parecoxib and remifentanil
Parecoxib IV and remifentanil infusion
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Harald Lenz, MD | +4723015427 | harald.lenz@medisin.uio.no |
| Contact: Johan Raeder, Prof.,MD,PhD | +4722119690 | johan.rader@medisin.uio.no |
| Norway | |
| Ullevaal University Hospital | |
| Oslo, Norway, 0407 | |
| 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 ( Ullevaal University Hospital ) |
| Study ID Numbers: | 2008-000904-10 |
| Study First Received: | November 4, 2008 |
| Last Updated: | November 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00785863 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs |
|
hyperalgesia remifentanil ketorolac |
parecoxib COX-1 inhibitor COX-2 inhibitor |
|
Signs and Symptoms Sensation Disorders Somatosensory Disorders Parecoxib Remifentanil |
Ketorolac Neoplasm Metastasis Neurologic Manifestations Ketorolac Tromethamine Hyperalgesia |
|
Anesthetics, Intravenous Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Anesthetics Central Nervous System Depressants Enzyme Inhibitors Pharmacologic Actions Anesthetics, General |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Analgesics, Opioid |
