Patient-controlled Subcutaneous Analgesia Using Sufentainil or Morphine in Home Care Treatment in Patients With Stage III-IV Cancer: A Multi-Center Randomized Controlled Clinical Trial

Purpose: Patient-controlled subcutaneous analgesia (PCSA) with sufentanil is an alternative analgesia strategy in patients with stage III-IV cancer; however, its efficacy and safety have not been fully investigated.

Methods: From May 10, 2017 to November 10, 2017, 120 patients with stage III-IV cancer suffering from moderate to severe pain were prospectively enrolled from six hospitals and randomized to receive PCSA with morphine (control group) or sufentanil (intervention group). Before the PCSA and on days 1, 3, 7, 14, 28, and 56 after treatment, the numeric rating scale (NRS) and 36-item Short Form health survey (SF-36) were completed for each patient and the side effects were also recorded.

Results: No significant differences (P > .05) were observed in the preoperative NRS score and the SF-36 parameters between the two groups. Patients in the intervention group achieved better pain relief, as indicated by lower NRS scores at days 14 (P = .040), 28 (P < .001), and 56 (P < .001) after PCSA device implantation (vs control group). Furthermore, the patients in the intervention group also achieved a better life quality, as indicated by the physical role, general health, social function body pain, and mental health scores. Finally, the patients receiving sufentanil showed lower levels of nausea and somnolence than those in the control group.

Conclusion: PCSA with sufentanil achieves better pain control and life quality as well as fewer adverse reactions in stage III-IV cancer patients with pain and may be a promising pain management in these patients.

Trial registration: This study was registered at chictr.org.cn with the trial number: ChiCTR-IPR-17011280.

Keywords: 36-item Short Form health survey; advanced cancer; numeric rating scale; patient-controlled subcutaneous analgesia; sufentanil.