Comparison of Efficacy of Transdermal Fentanyl Patch in Treatment of Chronic Soft Tissue Cancer Pain With Placeboin A Double-Blind Randomized Clinical Trial

Pain due to cancer is one of the major problems of patients affected by malignancies. There are many methods applied for cancer pain management of which opioids consumption is the most important method. Fentanyl is a synthetic opioid represented as a trans- dermal patch used for cancer chronic pain relief. In this study, we evaluated effectiveness of trans-dermal fentanyl patch comparing with placebo in cancer pain. This study was designed and performed as a double-blind randomized clinical trial. Patients affected by soft tissue tumors with chronic pain referred to Imam Khomini Hospital during 1385-1386 were investigated and divided randomly into trans-dermal fentanyl patch and placebo groups. The patches appearance in both the groups were the same. Pain severity was measured by visual analogue scale (VAS) 24, 48 and 72 hours after beginning of treatment. Repeated measurement analysis of variances was used. A total number of 166 patients affected by cancer were divided into two groups–trans dermal group (86 patients) and placebo (80 patients).There was the same age and sex distribution. According to repeated measurement analyses, the pain severity was significantly reduced in trans-dermal fentanyl group more than that of the placebo group (p=0/07). The incidence of side effects was 62 cases (72%) in fentanyl patch group and 31 cases (39%) in placebo group which emphasized that the side effect in trans-dermal fentanyl patch group was more than placebo group significantly (p=./001).Discussion & The accomplished data suggest that trans-dermal fentanyl patch is an effective and safe method in reducing pain in patients affected by soft tissue tumors. Furthermore, trans-dermal fentanyl patch can improve the quality of life in patients affected by soft tissue tumors.