A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- Change in Pain Assessment
研究概览
简要总结
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
- •Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
排除标准
- •Use of an non-steroidal anti-inflammatory drug within the previous six hours
- •Use of acetaminophen within the previous six hours
- •Use of an opioid within the previous ten days
- •Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
研究组 & 干预措施
Acetaminophen
Acetaminophen alone
干预措施: Acetaminophen (Drug)
Oxycodone/ acetaminophen
Oxycodone + acetaminophen
干预措施: Acetaminophen (Drug)
Oxycodone/ acetaminophen
Oxycodone + acetaminophen
干预措施: Oxycodone (Drug)
结局指标
主要结局
Change in Pain Assessment
时间窗: 2 hours following treatment
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
次要结局
- Sustained Pain Relief(Up to 48 hours following medication administration)
- Satisfaction With Medication(2 hours following treatment)
- Medication-related Adverse Events(2 hours following treatment)
- Adequacy of Analgesia(2 hours following treatment)