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Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

Award Number: UH3DE028860
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain - Project Summary/Abstract Everyday people die unnecessarily from opioid overdose-related addiction. With each opioid prescription a patient’s risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the United States, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are increasing their patient’s risk for addiction. To provide health care professionals, including dentists, and their patients with the best possible evidence for clinical based decision making when deciding upon analgesics for acute post-surgical pain management, we propose a double blind, stratified randomized clinical trial to demonstrate a combination of over-the-counter non-opioid containing analgesics is not inferior to than the most commonly prescribed opioid analgesic. Patients will be randomized within each study site/clinic, and stratified based upon gender due to differences in prescribing patterns and pain tolerance. We will use the impacted 3rd molar extraction model due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients will be randomized to receive either OPIOID (hydrocodone/acetaminophen) or NON-OPIOID (ibuprofen/acetaminophen). Outcomes data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision making tool, pain management, extraction difficulty and number of tablets taken will be collected enabling an experimental decision making tool to be developed. The proposed methods address the short comings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing acute pain for the entire post-operative period, not just the first 12 hours. They care about their ability to perform their normal daily functions without feeling queasy or nauseous, and they care about their ability to sleep at night. Parents of young people also care about the risks of subsequent opioid use, either related to treatments received or to subsequent use of leftover pills, which we will capture with objective measures of subsequent opioid prescriptions using PDMP data. This study would be the first to address these short comings. Upon successful completion of our proposed pragmatic clinical trial, patients and their families will be better able to make informed decisions regarding what pain medication (opioid vs. non-opioid) will best manage their pain after a dental procedure and will have a better understanding of the potential risks associated with opioid prescriptions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	000	5	5/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,130,794 )
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	003	5	7/17/2023	NON-COMPETING CONTINUATION	$1,130,794
2023	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	001	4	1/5/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,228,666
2023	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	002	4	3/1/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	000	3	1/5/2023	NON-COMPETING CONTINUATION	-$1,228,666
														Subtotal = $1,130,794

Issue Date FY: 2022 ( Subtotal = $2,960,004 )
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	001	4	9/2/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Oral Diseases and Disorders Research	000	4	7/21/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$2,960,004
														Subtotal = $2,960,004

Issue Date FY: 2021 ( Subtotal = $3,225,990 )
2021	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	005	3	7/16/2021	NON-COMPETING CONTINUATION	$3,127,499
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	004	2	4/20/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	001	2	2/28/2021	EXTENSION WITH OR WITHOUT FUNDS	$98,491
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	003	2	3/15/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	000	2	2/25/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	002	2	3/4/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $3,225,990

Issue Date FY: 2020 ( Subtotal = $3,431,977 )
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	000	2	7/31/2020	EXTENSION WITH OR WITHOUT FUNDS	$3,467,323
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	110 BERGEN ST	NEWARK	NJ	07103	ESSEX	USA	Oral Diseases and Disorders Research	001	2	8/14/2020	EXTENSION WITH OR WITHOUT FUNDS	-$35,346
														Subtotal = $3,431,977

Grand Total All Awards = $10,748,765

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Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

Award Number: UH3DE028860

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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