Objective. To demonstrate the efficacy and safety of long-term therapy with oxycodone in severe pain of scleroderma skin ulcers.
Design. Open study.
Setting and Patients. Twenty-nine consecutive patients, referred to our Rheumatology Unit during 2006, affected by systemic sclerosis complicated by painful long-standing skin ulcers entered in the study. In all cases, pain was classified as severe according to World Health Organization guidelines, and oxycodone chloridrate (Oxycontin®; Mundipharma Pharmaceuticals, Milan, Italy) was administrated at the dosage of 10–20 mg twice daily for a mean period of 7.9 ± 3.2 standard deviation months.
Outcome Measures. To evaluate the efficacy and safety of opioid therapy, the following parameters were recorded at standard time intervals: visual analog scale (VAS) pain, Pittsburgh sleep quality index (PSQI), hours of sleep per night, Health Assessment Questionnaire-Disability index, analgesics use (rescue therapy), side effects, vital signs, routine laboratory assessment.
Results. After 1 month of therapy, all patients experienced relief of pain (VAS decreased from 93.8 ± 8.72 to 56.7 ± 10.4, P < 0.0001), and better quality of sleep (total hours of sleep increased from 3.68 ± 1.28 to 5.27 ± 0.75, P < 0.0001; PSQI decreased from 9.72 ± 3.95 to 3.37 ± 1.04, P < 0.0001). These parameters further improved after 3 months of therapy and remained stable during the follow-up; moreover, an increase of daily dosage of oxycodone was never required. The observed side effects were always transient and mild; only constipation, when present, was persistent.
Conclusion. Oxycodone showed to be effective and safe in the treatment of pain due to severe scleroderma skin ulcers; contemporarily, it markedly improved the patient's compliance to local wound care procedures.