At a glance
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Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
In Brief
A Phase 3 clinical trial evaluating opioid-containing analgesic and two over-the-counter analgesics for Opioid Use. Active but no longer recruiting, targeting 1,815 participants across 5 sites.
Detailed Summary
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
Study Details
Timeline
Interventions
hydrocodone/ acetaminophen combination product
combination of over-the-counter analgesics (ibuprofen/acetaminophen)