Randomized Trial of Two Analgesics in Elderly ED Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Between group difference in change in NRS pain scores
研究概览
简要总结
The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.
详细描述
To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:
- Oxycodone/acetaminophen (5/325)
- Ibuprofen/acetaminophen (400/500)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（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
- •ED attending plans to discharge patient home with an oral analgesic
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
- •Ibuprofen or acetaminophen or opioids taken in past 4 hours
- •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
研究组 & 干预措施
Oxycodone/acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
干预措施: Oxycodone/acetaminophen (Drug)
Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (400 mg/500 mg)
干预措施: Ibuprofen/acetaminophen (Drug)
结局指标
主要结局
Between group difference in change in NRS pain scores
时间窗: 24 hours
Between group difference in change in NRS pain scores at 24 hours
次要结局
- Between group difference in side effects(24 hours, 48 hours and 72 hours)
- Change in NRS pre and 2 hours post most recent dose of pain medication taken(24 hours)
- Satisfaction(24, 48, and 72 hours)
- Between group difference in Likert pain scores(24, 48, and 72 hours)
- Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to(24-72 hours)
- Between group difference in change in NRS pain scores at first followup contact(24-72 hours)
- Between group difference in change in NRS pain scores(48 hours and 72 hours)
- Want same medication again(24-72 hours)
- Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.(24-72 hours)
研究者
Andrew Chang
Professor
Albany Medical College