TY - JOUR
T1 - The Opioid Analgesic Reduction Study (OARS) Pilot
T2 - A Double-Blind Randomized Multicenter Trial
AU - Feldman, C. A.
AU - Fredericks-Younger, J.
AU - Desjardins, P. J.
AU - Malmstrom, H.
AU - Miloro, M.
AU - Warburton, G.
AU - Ward, B.
AU - Ziccardi, V.
AU - Fine, D. H.
AU - Greenberg, P.
AU - Andrews, T.
AU - Matheson, P. B.
AU - Lu, S. E.
N1 - Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Supported by National Institute of Dental and Craniofacial Research. (NIDCR stands for the National Institute of Craniofacial Research) of the National Institutes of Health awards under award numbers UG3DE028860 and UH3DE028860. The opinions and assertions in this article are those of the authors and are not to be construed as necessarily representing the views of the organizations the authors are affiliated with, the organizations that participate as network regions, or the National Institutes of Health. Publisher Copyright: © International Association for Dental Research and American Association for Dental, Oral, and Craniofacial Research 2023.
PY - 2023
Y1 - 2023
N2 - Background: With addiction rates and opioid deaths increasing, health care providers are obligated to help stem the opioid crisis. As limited studies examine the comparative effectiveness of fixed-dose combination nonopioid analgesia to opioid-containing analgesia, a comparative effectiveness study was planned and refined by conducting a pilot study. Methods: The Opioid Analgesic Reduction Study (OARS) pilot, a stratified, randomized, multisite, double-blind clinical trial, was designed to test technology and procedures to be used in the full OARS trial. Participants engaged in the full protocol, enabling the collection of OARS outcome data. Eligible participants reporting to 1 of 5 sites for partial or full bony impacted mandibular third molar extraction were stratified by biologic sex and randomized to 1 of 2 treatment groups, OPIOID or NONOPIOID. OPIOID participants were provided 20 doses of hydrocodone 5 mg/acetaminophen 300 mg. NONOPIOID participants were provided 20 doses of ibuprofen 400 mg/acetaminophen 500 mg. OARS outcomes data, including pain experience, adverse effects, sleep quality, pain interference, overall satisfaction, and remaining opioid tablets available for diversion, were collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitor. Results: Fifty-three participants were randomized with 50 completing the OARS pilot protocol. Across all outcome pain domains, in all but 1 time period, NONOPIOID was better in managing pain than OPIOID (P < 0.05 level). Other outcomes suggest less pain interference, less adverse events, better sleep quality, better overall satisfaction, and fewer opioid-containing tablets available for diversion. Discussion: Results suggest patients requiring impacted mandibular third molar extraction would benefit from fixed-dose combination nonopioid analgesia. Knowledge Transfer Statement: Study results suggest fixed-dose nonopioid combination ibuprofen 400 mg/acetaminophen 500 mg is superior to opioid-containing analgesic (hydrocodone 5 mg/acetaminophen 500 mg). This knowledge should inform surgeons and patients in the selection of postsurgical analgesia.
AB - Background: With addiction rates and opioid deaths increasing, health care providers are obligated to help stem the opioid crisis. As limited studies examine the comparative effectiveness of fixed-dose combination nonopioid analgesia to opioid-containing analgesia, a comparative effectiveness study was planned and refined by conducting a pilot study. Methods: The Opioid Analgesic Reduction Study (OARS) pilot, a stratified, randomized, multisite, double-blind clinical trial, was designed to test technology and procedures to be used in the full OARS trial. Participants engaged in the full protocol, enabling the collection of OARS outcome data. Eligible participants reporting to 1 of 5 sites for partial or full bony impacted mandibular third molar extraction were stratified by biologic sex and randomized to 1 of 2 treatment groups, OPIOID or NONOPIOID. OPIOID participants were provided 20 doses of hydrocodone 5 mg/acetaminophen 300 mg. NONOPIOID participants were provided 20 doses of ibuprofen 400 mg/acetaminophen 500 mg. OARS outcomes data, including pain experience, adverse effects, sleep quality, pain interference, overall satisfaction, and remaining opioid tablets available for diversion, were collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitor. Results: Fifty-three participants were randomized with 50 completing the OARS pilot protocol. Across all outcome pain domains, in all but 1 time period, NONOPIOID was better in managing pain than OPIOID (P < 0.05 level). Other outcomes suggest less pain interference, less adverse events, better sleep quality, better overall satisfaction, and fewer opioid-containing tablets available for diversion. Discussion: Results suggest patients requiring impacted mandibular third molar extraction would benefit from fixed-dose combination nonopioid analgesia. Knowledge Transfer Statement: Study results suggest fixed-dose nonopioid combination ibuprofen 400 mg/acetaminophen 500 mg is superior to opioid-containing analgesic (hydrocodone 5 mg/acetaminophen 500 mg). This knowledge should inform surgeons and patients in the selection of postsurgical analgesia.
KW - acetaminophen
KW - clinical trial
KW - hydrocodone
KW - ibuprofen
KW - oral and maxillofacial surgery
KW - pain
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U2 - https://doi.org/10.1177/23800844221144031
DO - https://doi.org/10.1177/23800844221144031
M3 - Article
SN - 2380-0844
JO - JDR Clinical and Translational Research
JF - JDR Clinical and Translational Research
ER -