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Randomized Controlled Trial
. 2019 Jun;98(24):e15505.
doi: 10.1097/MD.0000000000015505.

Efficacy and safety of sustained-release oxycodone compared with immediate-release morphine for pain titration in cancer patients: A multicenter, open-label, randomized controlled trial (SOCIAL)

Hongming Pan  1 , Peng Shen  2 , Qijin Shu  3 , Liqin Lu  4 , Suying Qian  5 , Yuefen Zhou  6 , Feng Han  7 , Qunyi Guo  8 , Zhiping Yang  9 , Jie Pan  10 , Qing Xu  11 , Peng Zhang  12 , Kaifeng Wang  13
Affiliations
Randomized Controlled Trial

Efficacy and safety of sustained-release oxycodone compared with immediate-release morphine for pain titration in cancer patients: A multicenter, open-label, randomized controlled trial (SOCIAL)

Hongming Pan et al. Medicine (Baltimore). 2019 Jun.

Abstract

Background: The study aims to investigate the effect and safety of sustained-release oxycodone hydrochloride as background dose on pain titration in patients with moderate-to-severe cancer pain.

Material and methods: Adult patients scheduled with a regular strong opioid for cancer-related pain were recruited and randomly assigned to sustained-release oxycodone group (tablets, 12 hourly) and immediate-release morphine group (5 mg initially, hourly). All patients were hourly reassessed for efficacy and dose titration.

Results: The primary end point was the number of titration cycles required to achieve adequate pain relief (numerical rating scale, NRS ≤ 3). Secondary end points included the proportion of patients achieving adequate pain relief during each cycle, potential predictive factors for titration performance, and side effects. Ninety (94.7%) patients in oxycodone group and 78 (86.7%) patients in morphine group achieved adequate pain control during 1 to 4 cycles of titration. Patients in oxycodone group reached adequate pain control within the first 2 cycles of titration, which was significantly shorter than morphine group wherein the number of titration cycles ranged from 1 to 4 (P = .034). Oxycodone prescription significantly increased the response rate of patients to morphine titration during the first cycle of titration (P = .010). The initial NRS score and oxycodone administration were significantly associated with titration performance. The mild or moderate adverse effects were similar in 2 groups, while severe adverse effects were only identified in morphine group (P = .001).

Conclusion: Use of background sustained-release oxycodone is more efficient and better tolerated on dose titration than immediate-release morphine.

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Conflict of interest statement

The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
The general titration procedures with or without sustained-release oxycodone as background dose for cancer pain management.
Figure 2
Figure 2
The pain level of 2 groups during the treatment.
Figure 3
Figure 3
Proportion of responders during titration with oxycodone or morphine.
See this image and copyright information in PMC

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