Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified. The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Paracetamol 500 mg
Placebo
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Vestre Viken Hospital Trust
Drammen, Drammen, Norway
Førde Hospital Trust
Førde, Førde, Norway
Østfold Hospital Trust
Sarpsborg, Grålum, Norway
Sørlandet Hospital Trust
Kristiansand, Kristiansand, Norway
Stavanger University Hospital
Stavanger, Stavanger, Norway
Helse Møre og Romsdal
Ålesund, Norway
Akershus University Hospital
Lørenskog, Norway
OsloUH
Oslo, Norway
Telemark Hospital Trust
Skien, Norway
...and 5 more locations
To establish whether placebo with strong opioids compared to paracetamol together with strong opioids provides non-inferior analgesia for cancer-related pain.
Numeric Rating Scale 0-10: Average pain intensity past 24 hours
Time frame: 7 days
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid related side effects.
Opioid Side Effects Questionnaire
Time frame: 7 days
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes global rating of improvement.
Patient Global Impression of Change
Time frame: 7 days
To establish whether placebo with strong opioids compared to paracetamol with strong opioids changes opioid requirements.
Opioid consumption
Time frame: 7 days
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