Paracetamol for Cancer Pain

Haraldsplass Deaconess Hospital

Status and phase: Unknown; Phase 4

Conditions: Advanced Cancer; Opioid Use, Unspecified

Treatments: Drug: paracetamol; Drug: placebo tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01313247

Par 06-0045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo pills

Placebo Comparator group

Description:

Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily

Treatment:

Drug: placebo tablets

oral paracetamol 4 g daily

Active Comparator group

Description:

Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily

Treatment:

Drug: paracetamol