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

C. A. Feldman; J. Fredericks-Younger; P. J. Desjardins; H. Malmstrom; M. Miloro; G. Warburton; B. Ward; V. Ziccardi; D. H. Fine; P. Greenberg; T. Andrews; P. B. Matheson; S. E. Lu

doi:10.1177/23800844221144031

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

C. A. Feldman, J. Fredericks-Younger, P. J. Desjardins, H. Malmstrom, M. Miloro, G. Warburton, B. Ward, V. Ziccardi, D. H. Fine, P. Greenberg, T. Andrews, P. B. Matheson, S. E. Lu

Rutgers, The State University

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	American English
Pages (from-to)	72-84
Number of pages	13
Journal	JDR Clinical and Translational Research
Volume	9
Issue number	1
DOIs	https://doi.org/10.1177/23800844221144031
State	Published - Jan 2024

ASJC Scopus subject areas

General Dentistry

Keywords

acetaminophen
clinical trial
hydrocodone
ibuprofen
oral and maxillofacial surgery
pain

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10.1177/23800844221144031

Cite this

Feldman, C. A., Fredericks-Younger, J., Desjardins, P. J., Malmstrom, H., Miloro, M., Warburton, G., Ward, B., Ziccardi, V., Fine, D. H., Greenberg, P., Andrews, T., Matheson, P. B., & Lu, S. E. (2024). The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial. JDR Clinical and Translational Research, 9(1), 72-84. https://doi.org/10.1177/23800844221144031

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title = "The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial",

abstract = "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.",

keywords = "acetaminophen, clinical trial, hydrocodone, ibuprofen, oral and maxillofacial surgery, pain",

author = "Feldman, {C. A.} and J. Fredericks-Younger and Desjardins, {P. J.} and H. Malmstrom and M. Miloro and G. Warburton and B. Ward and V. Ziccardi and Fine, {D. H.} and P. Greenberg and T. Andrews and Matheson, {P. B.} and Lu, {S. E.}",

note = "Publisher Copyright: {\textcopyright} International Association for Dental Research and American Association for Dental, Oral, and Craniofacial Research 2023.",

year = "2024",

month = jan,

doi = "10.1177/23800844221144031",

language = "American English",

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Feldman, CA , Fredericks-Younger, J, Desjardins, PJ, Malmstrom, H, Miloro, M, Warburton, G, Ward, B, Ziccardi, V , Fine, DH, Greenberg, P, Andrews, T, Matheson, PB & Lu, SE 2024, 'The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial', JDR Clinical and Translational Research, vol. 9, no. 1, pp. 72-84. https://doi.org/10.1177/23800844221144031

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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 - Publisher Copyright: © International Association for Dental Research and American Association for Dental, Oral, and Craniofacial Research 2023.

PY - 2024/1

Y1 - 2024/1

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.

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KW - clinical trial

KW - hydrocodone

KW - ibuprofen

KW - oral and maxillofacial surgery

KW - pain

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

Abstract

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Keywords

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