title: Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: a multicenter, randomized, double-blinded, placebo-controlled trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  Patients with bone-cancer pain, already on opioids, obtain clinically important, additional pain-control, with regular oxycodone/paracetamol dosing.
authors.affiliation: National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China. simalei@yahoo.cn
authors.forename: L
authors.initials: L
authors.lastname: Sima
authors.forename: W X
authors.initials: WX
authors.lastname: Fang
authors.forename: X M
authors.initials: XM
authors.lastname: Wu
authors.forename: F
authors.initials: F
authors.lastname: Li
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000150:complications* / Q000556:secondary; D059390:Breakthrough Pain / Q000188:drug therapy / Q000453:epidemiology; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000627:therapeutic use; D010098:Oxycodone / Q000008:administration & dosage / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; C514822:oxycodone-acetaminophen; D000082:Acetaminophen; D009020:Morphine; D010098:Oxycodone; D005283:Fentanyl