None listed
Conditions
Brief summary
The aim of this study is to determine the efficacy of paracetamol in relieving pain suffered by patients with advanced cancer taking regular opioids. It is hypothesised that 1. Paracetamol prescribed in addition to regular opioids will not improve analgesia compared to opioids alone in patients with pain from advanced cancer, and; 2. combining n-of-1 trials from multiple subjects provides a feasible variation on randomised controlled trials (RCTs) in palliative care (PC) to produce population evidence of high quality.
Interventions
The Intervention treatment will be SR paracetamol 665 mg tabs (encapsulated) to be taken orally with water.
The patient will be randomly assigned to one drug. The patient will then be administerd the drug 3 to 4 times daily in a 3 day period. The drug will then be switched. The patient will then be administered the second drug 3 to 4 times daily for a 3 day period. The 6 day period is called a cycle. The cycle will be repeated 3 times.
A washout period will be registered on the first day of ea
The Intervention treatment will be SR paracetamol 665 mg tabs (encapsulated) to be taken orally with water. The patient will be randomly assigned to one drug. The patient will then be administerd the drug 3 to 4 times daily in a 3 day period. The drug will then be switched. The patient will then be administered the second drug 3 to 4 times daily for a 3 day period. The 6 day period is called a cycle. The cycle will be repeated 3 times. A washout period will be registered on the first day of each 3 day period. On these day, pain scores will not be included in the final analysis.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) aged >18 years b) a clinical diagnosis of chronic cancer-related pain with a Brief Pain Inventory (BPI) average pain score of < 3 over previous 24 hours; c) taking a regular dose of opioid analgesia (excluding codeine or tramadol) with no change in baseline opioid dose in the 48 hours prior to study d) no more than three doses of breakthrough opioid/day in the 48 hours prior to trial commencement and no increase in dose of breakthrough during this time e) a stable dose of other regular pain medications (i.e. coanalgesics) for at least 48 hours prior to trial commencement. Patients already on paracetamol are eligible, but must also stop paracetamol 3 days before the trial; f) no intervention e.g. radiotherapy, chemotherapy, surgery that might alter pain levels during the 2 weeks prior to the study period or plans to undergo such during the study period; g) an intact Gastro Intestinal tract (necessary for absorption of extended release preparations), i.e. no bowel obstruction, no colostomy/ileostomy h) ability to give fully informed written consent and complete all trial requirements including daily pain diaries.
Exclusion criteria
a) liver function (Aspartate Transaminase (AST), Alanine Transaminase (ALT)) >1.5x upper limit of normal, total bilirubin outside normal range; b) allergy or sensitivity to paracetamol c) cognitive impairment that in the clinician’s opinion would preclude fully informed consent or ability to complete study requirements d) life expectancy less than 6 weeks e) a poor understanding of written or spoken English that would preclude completion of all trial requirements
Outcome results
None listed