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-totreat
set, 89Æ4% completed the 3-day efficacy phase. PIDs
were 0Æ9 and 0Æ3 in the oxycodone/paracetamol and placebo
groups respectively, on day 1 (P < 0Æ001), and 1Æ5 and 0Æ3
respectively on day 3 (P < 0Æ001). Thirty-eight patients in the
treatment group, and 58 in the placebo group, suffered
breakthrough pain on day 3 (P < 0Æ001). The SF-6D score
decreased to 21Æ2 ± 2Æ5 in the oxycodone/paracetamol group
at the end of the phase (P = 0Æ001). 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.