Comparison of the Efficacy of Transdermal Fentanyl in the Treatment of Chronic Soft Tissue Cancer Pain with Placebo in 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 for management of cancer pain and opioid consumption is the most important method. Fentanyl is a synthetic opioid which is represented as a transdermal patch used for chronic cancer pain relief. In this study we evaluated the effectiveness of transdermal fentanyl patch as compared to placebo in cancer pain. Patients and This study was designed and performed as a double blind randomized clinical trial. Patients affected by soft tissue tumors with chronic pain who had referred to Cancer institute of Imam Khomini Hospital during 2006-07 were included and divided randomly into transdermal fentanyl patch and placebo groups. The appearance of the patches in both groups was the same. Pain severity was measured with Visual Analogue Scale(VAS) 24, 48 and 72 hours after the initiation of treatment. Data analysis was done by SPSS V. 13 software.Quantitative data were shown with mean(SD) and qualitative data were presented with frequency. Chi- square and t-tests were used for comparison of the data between the two groups.Repeated measurement analysis of variance was used for evaluating the effect of time and its relation with the medicine. p<0.05 was considerd as statistically significant. A sum of 166 patients affected by cancer were divided in two groups –transderamal group(86 patient) and placebo group(80 patients).There was the same age and sex distribution in both the groups. According to repeated measurement analysis, the pain severity was significantly reduced in the transdermal fentanyl group as compared to the placebo group(p=0.07). The incidence of side effects was observed in 62 patients (72%) in fentanyl patch group and 31 patients (39%) in placebo group emphasizing the fact that the side effects were significantly more in the transdermal fentanyl patch group as compared to the placebo group (p=0.001) The data suggest that transdermal fentanyl patch is an effective and safe method in reducing pain in patients affected by soft tissue tumors.Also it can improve the quality of life in this group of patients.