A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Patient Global Impression of Change
研究概览
简要总结
The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of 18 to no upper limit
- •Chronic pain of nociceptive, neuropathic, or mixed origin
- •Patients with chronic non cancer pain
- •Ongoing chronic opioid treatment with either oral morphine or oxycodone (long term - more than 3 months of at least a total daily opioid dose of 60 mg morphine or of 30 mg oxycodone)
- •Pain of moderate intensity (>4, on the numerical scale 0-10) despite ongoing opioid therapy>
- •Non-pregnant, non-lactating women
- •Sufficient language skills to communicate with research staff
排除标准
- •Non-ambulatory patients
- •Clinically significant respiratory, renal, hepatic, or cardiac disease.
- •Documented diagnosis of sleep apnea (the study physician may exclude patients who present with clinical features and complaints suggestive of a diagnosis of probable sleep apnea)
- •History of illicit drug or alcohol dependence or abuse, abnormal drug taking / seeking behaviors
- •Severe depression (> 26 on the BDI)
- •Patients who exhibit a score on the Mini Mental Status Exam (MMSE) of 26 or less. (The range of scores for mild dementia is 21-26 on the MMSE).
- •Workman compensation, current or pending medical-legal litigation
- •Hypersensitivity to study medication (oxymorphone)
研究组 & 干预措施
oxymorphone
participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
干预措施: Oxymorphone (Drug)
结局指标
主要结局
Change in Patient Global Impression of Change
时间窗: baseline and 12 hours
PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)
Brief Pain Inventory
时间窗: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment
次要结局
未报告次要终点