A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

Icahn School of Medicine at Mount Sinai12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

OxymorphoneDRUG

IV PO

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Icahn School of Medcine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change in Patient Global Impression of Change

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)

Time frame: baseline and 12 hours

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

Data from ClinicalTrials.gov

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