Modulation of Remifentanil-induced Postinfusion Hyperalgesia
NCT ID: NCT00785863
Last Updated: 2011-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2008-12-31
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Opioid-induced Hyperalgesia After Remifentanil Infusion
NCT01702389
Pre-operative Ketorolac Administration Has no Pre-emptive Analgesic Effect Following Total Abdominal Hysterectomy
NCT02642718
The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection
NCT02408146
Remifentanil and Hyperalgesia: Gradual Withdrawal Versus Immediate Discontinuation
NCT03110653
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
NCT01859585
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Placebo IV before placebo infusion
Remifentanil
Remifentanil
placebo IV and remifentanil infusion
Ketorolac and remifentanil
Ketorolac and remifentanil
Ketorolac IV and remifentanil infusion
Parecoxib and remifentanil
Parecoxib and remifentanil
Parecoxib IV and remifentanil infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo IV before placebo infusion
Remifentanil
placebo IV and remifentanil infusion
Ketorolac and remifentanil
Ketorolac IV and remifentanil infusion
Parecoxib and remifentanil
Parecoxib IV and remifentanil infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oslo
OTHER
Rikshospitalet University Hospital
OTHER
Ullevaal University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ullevaal University Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harald Lenz, MD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Johan Raeder, Prof.,MD,PhD
Role: STUDY_DIRECTOR
Ullevaal University Hospital
Audun Stubhaug, Prof.,MD,PhD
Role: STUDY_DIRECTOR
Rikshospitalet University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ullevaal University Hospital
Oslo, Oslo County, Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-000904-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.