Paracetamol for Cancer Pain

Advanced Cancer Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Opioid Use, Unspecified

• NCT number: NCT01313247
• Study type: Interventional
• Source: Haraldsplass Deaconess Hospital
• Contact: Jan Henrik Rosland, MD, PhD
• Phone: +4755979400
• Email: jhro@haraldsplass.no
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2011
• Completion date: December 2012