A Pilot Study of Rapid Opioid Rotation and Titration of Oxymorphone
Overview
- Phase
- N/A
- Intervention
- Oxymorphone
- Conditions
- Pain
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Patient Global Impression of Change
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
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
Intervention: Oxymorphone
Outcomes
Primary Outcomes
Change in Patient Global Impression of Change
Time Frame: 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
Time Frame: Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment