Paracetamol for Cancer Pain

Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids

Randomised, double-blind placebo controlled cross-over trial

Main goal:

Optimize the medical pain treatment for patients with advanced cancer disease

Study goal:

Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine > 100 mg/d.

National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.

Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.

Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.

Inclusion Criteria:

• Adults (> 18 years) of both sexes
• Diagnosed with advanced cancer disease
• Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to > 100 mg oral morphine daily
• NRS median pain score last 24 hrs > 4
• Able to take tablets (paracetamol) orally

Exclusion Criteria:

• Mental or physical deficiency precluding data collection.
• Reduced liver function judged with bilirubin, INR and transaminases
• Anticoagulation with warfarin
• Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
• Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.