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Efficacy of oxycodone/paracetamol for patients with bone‐cancer pain: a multicenter, randomized, double‐blinded, placebo‐controlled trial
Author(s) -
Sima L.,
Fang W. X.,
Wu X. M.,
Li F.
Publication year - 2012
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.2010.01239.x
Subject(s) - medicine , oxycodone , double blinded , placebo , randomized controlled trial , anesthesia , cancer pain , bone pain , surgery , cancer , opioid , receptor , alternative medicine , pathology
Summary 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.