Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
研究概览
简要总结
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
详细描述
To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Hydrocodone/acetaminophen (5/325)
- Codeine/acetaminophen (30/300)
- Ibuprofen/acetaminophen (400/1000)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complaint of acute pain of < 7 days duration
- •Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
- •Radiologic evaluation is planned
排除标准
- •Inability to confirm reliable means of phone followup.
- •Past use of methadone
- •Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
- •History of an adverse reaction to any of the study medications
- •Opioids taken in the past 24 hours
- •Ibuprofen or acetaminophen taken in past 8 hours
- •Pregnancy by either urine or serum HCG testing
- •Breastfeeding per patient report
- •History of peptic ulcer disease
- •Report of any prior use of recreational narcotics
- •Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
- •Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
研究组 & 干预措施
Oxycodone/acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
干预措施: Oxycodone/acetaminophen (Drug)
Hydrocodone/acetaminophen
Hydrocodone/acetaminophen (5 mg/300 mg)
干预措施: Hydrocodone/acetaminophen (Drug)
Codeine/acetaminophen
Codeine/acetaminophen (30 mg/300 mg)
干预措施: Codeine/acetaminophen (Drug)
Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (400 mg/1000 mg)
干预措施: Ibuprofen/acetaminophen (Drug)
结局指标
主要结局
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
时间窗: 2 hours
Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
次要结局
- Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores(1 hour)
研究者
Andrew Chang, MD
PI
Montefiore Medical Center