A Randomised Controlled Trial Investigating Possible Additive AnalgesicEffects of Paracetamol in Palliative Patients using Low-dose Strong Opioids

Phase 4

• Conditions: Analgesic benefits of paracetamol for palliative patients using low-dose strong opioids; Public Health - Health service research

• Registration Number: ACTRN12609000968279
• Lead Sponsor: Brisbane South Palliative Care Collaborative

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patients taking the equivalent of 50mg of oral morphine or less in a 24 hour period
2.Patients on stable (+/- 30% of total daily requirement) doses of opioid and non opioid analgesics for at least one week prior to recruitment
3.Baseline pain score greater than or equal to two
4.Prepared to take oral paracetamol (4 gm daily) if not currently prescribed
5.If currently prescribed, prepared to stop their usual dose of paracetamol and use of any breakthrough medications with a paracetamol additive
6.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 Criteria

1.Palliative patients less than 18 years of age
2.Patients whose pain is considered clinically to be primarily neuropathic
3.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
4.Expected survival less than 2 weeks
5.Patients clinically jaundiced
6.Patients experiencing regular febrile events
7.Any patient who, in the researchers’ opinion, is unable to comply with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified