Paracetamol with Strong Opioids for cancer pain (PaSO)
Research type
Research Study
Full title
A double blind randomised parallel group trial of paracetamol versus placebo in conjunction with strong opioids for cancer related pain.
IRAS ID
193574
Contact name
Marie Fallon
Contact email
Eudract number
2016-000197-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Current national guidelines recommend all patients with cancer related pain should be prescribed paracetamol, even patients receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown to be beneficial in other conditions, it has not been shown to further improve cancer related pain. We know that patients can find taking tablets burdensome and we hope to clarify whether the inconvenience of taking eight extra paracetamol tablets per day can be justified.
We will recruit voluntary participants who are taking a combination of paracetamol (full dose, 1g four times a day) and a strong opioid who still have some pain. For the first few days they will be assessed while taking their usual medication. They will then be randomly allocated to receive either paracetamol or a placebo instead for 13 days.
Participants will record pain scores, how much opioid pain killer they need and any side effects in a daily diary for 14 days. The information will be collected by a researcher via daily phone calls. More detailed assessments of pain and distress will also be made at the start, mid-point and end of the study. Neither the participant, the doctors looking after them or the researcher will know whether they are taking placebo or paracetamol. This prevents any outside influence on the pain scores.
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0110
Date of REC Opinion
1 Jul 2016
REC opinion
Favourable Opinion