A Randomised Controlled Trial Investigating Possible Additive Analgesic Effects of Paracetamol in Palliative Patients using Low-dose Strong Opioids
Brisbane South Palliative Care Collaborative
50 participants
Jan 1, 2010
Interventional
Conditions
Summary
There is little evidence base to direct physicians as to when to use paracetamol for the management of pain in palliative patients who require opioids. In particular, it is not known whether the addition of eight large paracetamol tablets (4gm) to the daily medications of patients, using low-dose strong opioids, improves pain control or merely adds to patients’ tablet burden. This study is a double-blind randomised controlled trial, designed to investigate any analgesic benefits of paracetamol for patients using low-dose strong opioids. It requires patients to take either 4gm of paracetamol or placebo in addition to their usual daily opioids for five days and then to swap to placebo or 4gm of paracetamol for the next five days. Patients are asked to complete a daily diary throughout the ten day study period that records subjective and objective measures of pain control, aspects of common opioid side effects and quality of life. These records will be quantitatively analysed for statistical significance using paired t-test.
Eligibility
Inclusion Criteria7
- Patients taking the equivalent of 50mg of oral morphine or less in a 24 hour period
- Patients on stable (+/- 30% of total daily requirement) doses of opioid and non opioid analgesics for at least one week prior to recruitment
- Baseline pain score greater than or equal to two
- Prepared to take oral paracetamol (4 gm daily) if not currently prescribed
- If currently prescribed, prepared to stop their usual dose of paracetamol and use of any breakthrough medications with a paracetamol additive
- Ability to give informed consent in English
- Mini Mental State Examination score of at least 25 out of 30 (to be repeated at 5 day intervals)
Exclusion Criteria7
- Palliative patients less than 18 years of age
- Patients whose pain is considered clinically to be primarily neuropathic
- Patients who have received treatments in the two weeks before the study that are likely to impact on pain levels (eg radiotherapy) or who receive such therapy during the study period
- Expected survival less than 2 weeks
- Patients clinically jaundiced
- Patients experiencing regular febrile events
- Any patient who, in the researchers’ opinion, is unable to comply with the protocol
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Interventions
All patients will receive five days of paracetamol (two 500mg tablets per oral four times a day) and five days of an identical appearing placebo. The primary outcome, pain, will be assessed subjectively by patients completing a daily diary ( of numerical ratings of pain on an 11 point Likert-type scale with values ranging from 0 (none) to 10 (unbearable), for each of the 5 days of both treatments. In addition, the numbers of breakthrough medications used each day will be recorded. Secondary outcomes of subjective ratings of nausea and vomiting, cognitive impairment (drowsiness and unclear thinking), constipation and overall feeling of well-being will also be assessed using 11 point Likert-type scales. A one day washout period dictates that only data from the last four days of each treatment arm will be analysed to exclude the influence of possible carryover effects. At the completion of the study patients will be asked to rank their global satisfaction with the two treatments. They will be given the option of continuing with paracetamol and asked the reason for their choice.
Locations(1)
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ACTRN12609000968279