Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: a multicenter, randomized, double-blinded, placebo-controlled trial.

Abstract

WHAT IS KNOWN AND OBJECTIVE:

Bone-cancer pain is a common and refractory cancer pain. Opioids, on their own, do not control this type of pain well enough, and co-analgesics are necessary.

METHODS:

Patients with bone metastasis-related pain at Numeric Rating Scale ≥4 were enrolled to this randomized placebo-controlled trial. They had also received morphine or transdermal fentanyl patches for at least 1 week. During the 3-day efficacy phase, patients received placebo or 1-3 tablets of oxycodone/paracetamol (5/325 mg), four times daily for 3 days. All patients kept a daily pain diary. The primary endpoint was the Pain Intensity Difference (PID). Secondary endpoints were cases of breakthrough pain and rescue morphine consumption. Additional analyses included the Short Form-6 Dimensions (SF-6D) quality-of-life scale and a general impression (GI) of patient satisfaction with treatment at the end of the phase.

RESULTS AND DISCUSSION:

Of the 246 patients in the intent-to-treat set, 89·4% completed the 3-day efficacy phase. PIDs were 0·9 and 0·3 in the oxycodone/paracetamol and placebo groups respectively, on day 1 (P < 0·001), and 1·5 and 0·3 respectively on day 3 (P < 0·001). Thirty-eight patients in the treatment group, and 58 in the placebo group, suffered breakthrough pain on day 3 (P < 0·001). The SF-6D score decreased to 21·2 ± 2·5 in the oxycodone/paracetamol group at the end of the phase (P = 0·001). In the oxycodone/paracetamol group, 67% rated GI as good, very good, or excellent.

WHAT IS NEW AND CONCLUSION:

Patients with bone-cancer pain, already on opioids, obtain clinically important, additional pain-control, with regular oxycodone/paracetamol dosing.

• Authors: L Sima, W X Fang, X M Wu, F Li
• Journal: Journal of clinical pharmacy and therapeutics (J Clin Pharm Ther) Vol. 37 Issue 1 Pg. 27-31 (Feb 2012) ISSN: 1365-2710 [Electronic] England
• PMID: 21208247 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2011 Blackwell Publishing Ltd.

Chemical References

• Analgesics, Opioid
• Drug Combinations
• oxycodone-acetaminophen
• Acetaminophen
• Morphine
• Oxycodone
• Fentanyl

Topics

• Acetaminophen (administration & dosage, therapeutic use)
• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Analgesics, Opioid (administration & dosage, therapeutic use)
• Bone Neoplasms (complications, secondary)
• Breakthrough Pain (drug therapy, epidemiology)
• Double-Blind Method
• Drug Combinations
• Female
• Fentanyl (administration & dosage, therapeutic use)
• Humans
• Male
• Middle Aged
• Morphine (administration & dosage, therapeutic use)
• Oxycodone (administration & dosage, therapeutic use)
• Pain (drug therapy, etiology)
• Pain Measurement
• Patient Satisfaction
• Quality of Life
• Treatment Outcome