Modulation of Remifentanil-induced Postinfusion Hyperalgesia
|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.|
|ClinicalTrials.gov Identifier: NCT00785863|
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hyperalgesia, Secondary||Other: Placebo Drug: Remifentanil Drug: Ketorolac and remifentanil Drug: Parecoxib and remifentanil||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
|Placebo Comparator: Placebo||
Placebo IV before placebo infusion
|Active Comparator: 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
- H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi. [ Time Frame: during the study ]
- HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi. [ Time Frame: During the study ]
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
|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|