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
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
Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct
Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Pain reduction caused by paracetamol 4g/d
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Last day in each 3 days study period
Jan Henrik Rosland, MD, PhD
Haraldsplass Deaconess Hospital
Norway: Norwegian Medicines Agency