Mercadante, S., Porzio, G., Ferrera, P., Aielli, F., Verna, L., Tirelli, W., . . . Casuccio, A. (2009). Low doses of transdermal buprenorphine in opioid-naive patients with cancer pain: A 4-week, nonrandomized, open-label, uncontrolled observational study. Clinical Therapeutics, 31(10), 2134–2138.

To examine the effectiveness and side effects of transdermal buprenorphine in opioid-naive patients with cancer-related pain

Patients received an initial dose of transdermal buprenorphine: 17.5 mcg/hour, with patch changes every three days. For the treatment of breakthrough pain, patients received 5 mg oral morphine. Every 2–3 days, the transdermal buprenorphine dose was adjusted up to 70 mcg/hour. Each patient received adjuvant symptomatic drugs as needed. Patients were contacted weekly for adjustment of therapy. Patients completed rating scales of side effects and pain intensity at baseline, after 1 week, and at 4 weeks.

• Twenty-four patients completed all four weeks.
• Mean patient age was 67.2 years (SD = 11.9 years).
• Of all patients, 41% were female and 59% were male.
• The sample included multiple cancer types; gastrointestinal, breast, and lung cancers were the most frequent.

The setting type was unspecified. The site was Palermo, Italy.

Open-label observational trial

• Numeric scale, 0–10, to measure pain intensity
• Scale (0 = not at all, 3 = severe), to measure multiple symptoms
• Spitzer Quality of Life Index

• Pain intensity scores declined by 50% over the four-week period (p < 0.001).
• Transdermal buprenorphine dose increased significantly and had doubled by the end of the study. 
• Dry mouth and drowsiness were the most severe side effects.
• Of all patients, 15% discontinued the study because of poor compliance or the need for different pain management.

For the patients in this study, transdermal buprenorphine was effective for pain management and well tolerated.

• The study had a risk of bias due to no appropriate control group.
• The study had a relatively small sample.
• The duration of the study was very short; long-term effectiveness and side effects were not evaluated.
• The report provides mean scores regarding treatment side effects but does not provide the prevalence rates of the effects.

Authors pointed out that the World Health Organization analgesic ladder suggests a dose equivalent of approximately 35 mcg/hour.