Abstract | WHAT IS KNOWN AND OBJECTIVE: 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:
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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)
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Copyright | © 2011 Blackwell Publishing Ltd. |
Chemical References |
- Analgesics, Opioid
- Drug Combinations
- oxycodone-acetaminophen
- Acetaminophen
- Morphine
- Oxycodone
- Fentanyl
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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
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