Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,815
- 试验地点
- 9
- 主要终点
- Composite Pain 3
研究概览
简要总结
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results.
This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was a double-blinded study. The participant, care provider, site directors and site research coordinators were all blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An individual must meet all of the following criteria to be eligible to participate in the study:
- •Be able to understand the informed consent.
- •Provide signed and dated informed consent form
- •Be able to understand all directions for data gathering instruments in English
- •Be willing and able to comply with all study procedures and be available for the duration of the study
- •Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
- •Be 18 years or older
- •Be in good general health as evidenced by medical history
- •Women must agree to use one of the following methods of contraception while participating in this study:
- •contraceptive pill
- •intra-uterine device
- •abstinence
排除标准
- •Participants who self-report the following history will be excluded from participating:
- •History of gastrointestinal bleeding and/or peptic ulcer
- •History of renal disease (excluding kidney stones)
- •History of hepatic disease
- •History of bleeding disorder
- •History of respiratory depression
- •Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively
- •Active or untreated asthma
- •History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
- •Currently taking any of the following medications:
- •CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
- •CNS depressants.
- •Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
- •History of drug or alcohol abuse
- •Family history of drug or alcohol abuse in a first-degree relative
- •Has had no more than one opioid prescription filled within the past 12 months
- •Currently pregnant or lactating
- •Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- •Prior participation in this study
- •Inability or refusal to provide informed consent
研究组 & 干预措施
Opioid
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
干预措施: opioid-containing analgesic (Drug)
Non-Opioid
Combination of ibuprofen 400 mg/acetaminophen 500 mg
干预措施: two over-the-counter analgesics (Drug)
结局指标
主要结局
Composite Pain 3
时间窗: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Pain Average 1
时间窗: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Composite Pain 1
时间窗: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Composite Pain 2
时间窗: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Pain Worst 2
时间窗: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Pain Average 3
时间窗: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Pain Worst 1
时间窗: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Overall Satisfaction
时间窗: At time of post-operative visit (day 9 +/- 5 days)
Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Pain Worst 3
时间窗: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Composite Pain All
时间窗: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Worst All
时间窗: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average All
时间窗: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average 2
时间窗: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
次要结局
- Pain Interference 3(End of the second full day after surgery (day 3))
- Sleep 3(When first waking up the 3rd day after surgery)
- Number of Participants Receiving Rescue Medication(At post operative visit (9 days after surgery +/- 5 days))
- Sleep 1(When first waking up the day after surgery)
- Pain Interference 2(End of the first full day after surgery (day 2))
- Pain Interference All(First 7 days after surgery)
- Sleep 2(When first waking up the 2nd day after surgery)
- Pain Interference 1(End of the day of surgery (day 1))
- Sleep All(First 7 nights after surgery)
- Potential for Opioid Tablet Diversion(At post operative visit (9 days after surgery +/- 5 days))
研究者
Cecile A. Feldman, DMD
Dean and Professor
Rutgers, The State University of New Jersey