NCT01313247

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Haraldsplass Deaconess Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Opioid Use, Unspecified

Interventions

Type	Name	Description
DRUG	paracetamol	1000 mg 4 times daily
DRUG	placebo tablets	Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-03-11
• Last updated: 2011-03-11

Locations

1 site across 1 country: Norway