Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
阿片类镇痛减量研究 (OARS):管理术后急性手术疼痛
基本信息
- 批准号:10670330
- 负责人:
- 金额:$ 113.08万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-08-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcetaminophenAcuteAcute PainAcute pain managementAddressAdolescent and Young AdultAdverse effectsAdverse eventAdverse reactionsAgeAnalgesicsBehaviorCaringClient satisfactionClinicClinicalClinical ProtocolsConstipationDataDatabasesDecision MakingDentalDental CareDentistsDiarrheaDizzinessDoseDouble-Blind MethodDrowsinessEducational StatusElectronicsEmergency SituationEthnic OriginEuphoriaExhibitsExposure toFamilyFeelingFemaleFrequenciesFutureGenderGuidelinesHabitsHeadacheHealth PersonnelHealth ProfessionalHigh School StudentHourHouseholdHydrocodoneHydrocodone/AcetaminophenIbuprofenLightLightheadednessLocationMandibleMaxillaMeasuresMedical ElectronicsMethodsModelingMonitorNauseaOperative Surgical ProceduresOpioidOpioid AnalgesicsOutcomePainPain ThresholdPain managementParentsPatient riskPatientsPatternPersonsPolysomnographyPostoperative PainPostoperative PeriodPragmatic clinical trialPruritusRaceRandomizedRecommendationReportingRiskSchool-Age PopulationSerious Adverse EventSeveritiesSiteSleepTabletsTestingTimeUnited StatesUrinary RetentionVisitVomitingWritingaddictioncapsuleclinical decision-makingdaily functioningdiariesexpectationexperiencehigh schoolinterestmalemonitoring devicenon-opioid analgesicopioid abuseopioid misuseopioid mortalityopioid overdoseopioid usepain modelpain patientpain reliefpain sensitivitypillprescription opioidprogramsprospectiverandomized, clinical trialssatisfactionsleep qualitysupport toolssurgical painthird molar extractiontoolyoung adult
项目摘要
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.
项目总结/文摘
项目成果
期刊论文数量(2)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial.
- DOI:10.1186/s13063-022-06064-8
- 发表时间:2022-02-17
- 期刊:
- 影响因子:2.5
- 作者:Feldman CA;Fredericks-Younger J;Lu SE;Desjardins PJ;Malmstrom H;Miloro M;Warburton G;Ward B;Ziccardi V;Fine D
- 通讯作者:Fine D
The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial.
阿片类镇痛药减量研究 (OARS) 试点:双盲随机多中心试验。
- DOI:10.1177/23800844221144031
- 发表时间:2024
- 期刊:
- 影响因子:0
- 作者: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,S-E
- 通讯作者:Lu,S-E
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Cecile Feldman其他文献
Cecile Feldman的其他文献
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{{ truncateString('Cecile Feldman', 18)}}的其他基金
Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
阿片类镇痛减量研究 (OARS):管理术后急性手术疼痛
- 批准号:
10193996 - 财政年份:2020
- 资助金额:
$ 113.08万 - 项目类别:
Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
阿片类镇痛减量研究 (OARS):管理术后急性手术疼痛
- 批准号:
10227266 - 财政年份:2020
- 资助金额:
$ 113.08万 - 项目类别:
Opiod Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
阿片类镇痛减量研究 (OARS):管理术后急性手术疼痛
- 批准号:
10452705 - 财政年份:2020
- 资助金额:
$ 113.08万 - 项目类别:
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