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
Overview
- Phase
- Phase 4
- Intervention
- placebo tablets
- Conditions
- Advanced Cancer
- Sponsor
- Haraldsplass Deaconess Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain reduction caused by paracetamol 4g/d
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Placebo pills
Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily
Intervention: placebo tablets
oral paracetamol 4 g daily
Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily
Intervention: paracetamol
Outcomes
Primary Outcomes
Pain reduction caused by paracetamol 4g/d
Time Frame: Last day in each 3 days study period
Pain reduction in the active paracetamol arm, compared to placebo, corrected for difference in rescue medication intake.
Secondary Outcomes
- Overall satisfaction with the pain treatment(End of each 3 days study period)