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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pills | Placebo Comparator | Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily |
|
| oral paracetamol 4 g daily | Active Comparator | Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol | Drug | 1000 mg 4 times daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall satisfaction with the pain treatment | Total ESAS score Sweating during nighttime general wellbeing | End of each 3 days study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Henrik Rosland, MD, PhD | Contact | +4755979400 | 79387 | jhro@haraldsplass.no |
| Sindre Hoel, MD | Contact | +4755975000 | sindre.hoel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jan Henrik Rosland, MD, PhD | Haraldsplass Deaconess Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haraldsplass Deaconess Hospital | Bergen | 5009 | Norway |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo tablets | Drug | Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol |
|
|
| Aniline Compounds |
| D000588 | Amines |