Comparison of Analgesic Efficacy of Morphine Sulfate Immediate Release (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) for Acute Pain in Emergency Department Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)
研究概览
简要总结
Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency department and in outpatient settings. Both medications have a very high potential for abuse due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or "negative" effects (likeability). The highly addictive properties of these medications lead to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse, development of dependence and addiction, and, most importantly, death due to overdose. In contrast, several research papers demonstrated that administration of MSIR results in similar analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and rewarding associated effects. In addition, consumption of large doses of MSIR leads to dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there are no randomized controlled trials in the ED that directly compared analgesic efficacy of MSIR to Percocet
详细描述
The investigators' hypothesis is that MSIR coupled with acetaminophen will have similar if not better analgesic efficacy at 30 minutes and 1 hour than oxycodone coupled with acetaminophen for acute painful conditions in the emergency department.
This study will be a double-blind randomized clinical trial evaluation analgesic efficacy of orally administered MISIR+acetaminophen in comparison to Oxycodone+acetaminophen for treating pain. Patients will be enrolled from a single ED in a tertiary academic center.
Patients based on inclusion criteria will be randomized to receive either 1 tablet of 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen or 1 tablet 10mg Oxycodone combined with 650 mg Acetaminophen. All drugs will be crushed and given to the subjects in blinded fashion. Patients, physicians, nurses and research assistants will be blinded to drug assignment throughout the study. Medication will be prepared by on site pharmacist.
Pain will be reassessed at both 30 minutes, 45 minutes and 1 hour with the primary outcome of reduction in pain score by 1.3 points at 60 minutes. Assuming a 1.7 pain difference is minimally significant clinically with standard deviation of 3.0 (based on a previous study of morphine analgesia), a minimum of 50 patients per group will be needed for 80% power with alpha equal to 0.05.
Secondary outcomes will include any reported adverse effects; the requirement of additional analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18-64,
- •present to the Emergency department with moderate-to-severe acute pain that warrants an oral opioid analgesic.
- •pain score is above 5 and are deemed to require oral opioid at the discretion of the attending physician.
- •Painful conditions will include but will not be limited to acute traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.
排除标准
- •age <18, age >64,
- •subjects who received long acting opioids within 24 hours of presenting to ED
- •received short acting analgesics within 4 hours,
- •chronic pain,
- •pregnant patients,
- •patient refusal,
- •altered mental status,
- •known allergy to either morphine or oxycodone or acetaminophen,
- •history of substance and opioid abuse,
- •unstable vital signs, acute psychosis or incarceration.
- •subjects who received long acting opioids within 24 hours of presenting to ED;
- •chronic pain"
研究组 & 干预措施
MSIR and Acetaminophen Group
The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen
干预措施: Morphine Sulfate (Drug)
MSIR and Acetaminophen Group
The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen
干预措施: Acetaminophen (Drug)
Oxycodone and Acetaminophen Group
The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen
干预措施: Oxycodone (Drug)
Oxycodone and Acetaminophen Group
The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)
时间窗: 60 minutes
The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain.
次要结局
未报告次要终点
研究者
Antonios Likourezos
Co-Investigator
Maimonides Medical Center