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Transdermal fentanyl patch versus standard analgesia in postoperative oral submucous fibrosis patients: a triple blinded, randomised control trial

      Abstract

      Severe pain experienced by patients with oral submucous fibrosis (OSMF) compromises their physiotherapy and negatively affects the surgical outcome and the patient’s compliance. The main aim of this study was to develop a protocol for pain control in the management of OSMF postoperatively. This was a prospective, parallel with active control, double-arm, triple-blinded, randomised control trial (RCT) with 48 OSMF patients, randomised into two groups - Group A (control, n = 25): received non-opioid analgesics (NSAIDs) and Group B (cases, n = 23): received transdermal fentanyl patches (TFP). Pain and interincisal opening were measured on postoperative days 1, 3, 5, 7, 9, and 15, and on the1st and 3rd postoperative months. Quality of Life (QoL) was assessed preoperatively, on the 15th day postoperatively, and 3rd month postoperatively, and compliance was documented postoperatively on the 9th day. The transdermal fentanyl patch was found to have statistically significantly more effect in controlling severe pain during active mouth opening exercises, and thus significantly increased the patients’ compliance. Although there was increased mouth opening and QoL in the fentanyl group, the differences were statistically insignificant. Our study recommends the use of TFP for better pain control and compliance in postoperative OSMF patients.

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