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The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial.

C A Feldman1,2, J Fredericks-Younger1, P J Desjardins1

  • 1School of Dental Medicine, Rutgers University, Newark, NJ, USA.

JDR Clinical and Translational Research
|January 21, 2023
PubMed
Summary
This summary is machine-generated.

Fixed-dose nonopioid analgesia, specifically ibuprofen and acetaminophen, effectively managed pain after third molar extraction, outperforming opioid medications. This offers a safer alternative for postsurgical pain management.

Keywords:
acetaminophenclinical trialhydrocodoneibuprofenoral and maxillofacial surgerypain

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Area of Science:

  • Oral and Maxillofacial Surgery
  • Pain Management
  • Pharmacology

Background:

  • Rising addiction rates and opioid deaths necessitate alternatives to opioid analgesia.
  • Limited comparative effectiveness studies exist for fixed-dose nonopioid vs. opioid analgesia.
  • A pilot study refined methodology for a larger comparative effectiveness trial.

Purpose of the Study:

  • To evaluate the comparative effectiveness of nonopioid vs. opioid analgesia for impacted mandibular third molar extraction.
  • To test procedures and technology for the full Opioid Analgesic Reduction Study (OARS) trial.
  • To collect data on pain, adverse effects, sleep, and opioid diversion.

Main Methods:

  • A randomized, double-blind, multisite pilot clinical trial (OARS pilot).
  • Participants received either hydrocodone/acetaminophen (OPIOID) or ibuprofen/acetaminophen (NONOPIOID).
  • Data collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitors.

Main Results:

  • The nonopioid group (ibuprofen/acetaminophen) demonstrated superior pain management compared to the opioid group (hydrocodone/acetaminophen).
  • Nonopioid analgesia resulted in less pain interference, fewer adverse events, and better sleep quality.
  • Fewer opioid tablets were available for diversion in the nonopioid group.

Conclusions:

  • Fixed-dose nonopioid combination analgesia (ibuprofen/acetaminophen) is a beneficial alternative for postsurgical pain management.
  • Results support the use of nonopioid analgesia for patients undergoing impacted mandibular third molar extraction.
  • This finding can guide surgeons and patients in selecting safer postsurgical pain relief options.