مقايسه اثربخشي چسب فنتانيل ترانس درمال و دارونما در درمان درد مزمن بيماران مبتلا به سرطان بافت نرم در يك كارآزمايي باليني تصادفي دو سوكور

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

Introduction : 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 co nsumption is the most import ant metho d. Fe ntany l is a synthetic opioid represe nted as a trans- de rmal patch used for ca ncer chro nic pain reli ef. In this study , we eva luated e ffec tive ne ss of tran sdermal fe ntanyl patch comparing with placebo in ca ncer pain. Mat erials & Methods: This study was designed and perfor med as a doubl e-bli nd randomized cl inical trial. Pat ients affected by soft tissue tumors with chronic pain refe rred to Imam Khomi ni Hospi tal during 1385-1386 were investigated and divided randomly into trans-dermal fentanyl patch and place bo groups. The patche s appearance in both the groups were the sa me. Pain seve rity was measured by visua l analogue sca le (VAS) 24, 48 and 72 hours after begin ning of treatment. Repeated meas urement analys is of variances was used . Accepted: 11 Mar, 2009) Findin gs: A total num ber of 166 patien ts affec ted by cancer were divided into two groups-trans dermal gro up (86 patient s) and placebo (80 patients). There was the same age and sex distribu tion . According to re peated measurement ana lyses . the pain severity was signif icantly redu ced in trans-dermal fentanyl gro up more than that of the placebo group (p=O/07). The incidence of side effects was 62 cases (72%) in fentanyl patch group and 3 1 cases (39 %) in placebo group which emphasized that the side effec t in trans-dermal fen tanyl patch gro up was more than placebo group sig nificantly (p=.lOO 1) . Discussion & Conclusion: The acco mplished data suggest that transdermal fenta nyl patch is an effec tive and safe method in redu cing pain in patients affected by soft tissue tuma rs. Furthermore, trans-derm al fentany l patch can improve the qu ality of life in patient s affected by soft tissue tumors.