A double-blind, dose-ranging study to determine the optimal dose of oral morphine or oxycodone needed to treat breakthrough pain for people on regular opioid in the palliative care setting.
Phase 3
Active, not recruiting
- Conditions
- Breakthrough PainAlternative and Complementary Medicine - Pain management
- Registration Number
- ACTRN12605000366651
- Lead Sponsor
- Repatriation General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 138
Inclusion Criteria
English speaking, AKPS performance status of 100 to 30, Calculated creatinine clearance of > 20 ml/minVenous blood sample for creatinine level, Stable background oral opioid for the previous 4 days, Successfully using breakthrough doses, Physically able to complete study measures.
Exclusion Criteria
Confusion, Uncontrolled nausea or vomiting, Suspected gastro-intestinal obstruction, Known or suspected hypersensitivity to morphine or oxycodone, Past history of substance misuse, Declines to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the optimal dose of either oral immediate release morphine or oxycodone solution for breakthrough pain based on the % reduction in pain scores at 30 minutes between the three doses.[At 30 minutes between the three doses.]
- Secondary Outcome Measures
Name Time Method 1. To determine lowest effective dose of either oral immediate release morphine or oxycodone solution for breakthrough pain.[30,60 and 120 minutes after study dose];2. To determine difference in the side effect profile between doses of study doses.[30,60 and 120 minutes after study dose];A subset of 15 patients using Morphine as their regular breakthrough medication will be asked to provide blood samples for the purposes of an exploratory pharmacokinetic study .[Not Applicable ]