Research Article| Volume 60, ISSUE 9, P1246-1253, November 2022

Download started.


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


      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.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to British Journal of Oral and Maxillofacial Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Warnakulasuriya S.
        • Johnson N.W.
        • van der Waal I.
        Nomenclature and classification of potentially malignant disorders of the oral mucosa.
        J Oral Pathol Med. 2007; 36: 575-580
        • Guo J.
        • Xie H.
        • Mao S.
        • et al.
        Efficacy of hyaluronidase combined with corticosteroids in treatment of oral submucous fibrosis: a meta-analysis of randomized controlled clinical trials.
        J Oral Pathol Med. 2020; 49: 311-339
        • Mahato B.
        • Prodhan C.
        • Mandal S.
        • et al.
        Evaluation of efficacy of curcumin along with lycopene and piperine in the management of oral submucous fibrosis.
        Contemp Clin Dent. 2019; 10: 531-541
        • Balabaskaran K.
        Treatment options for oral submucous fibrosis.
        IOSR J Dent Med Sci. 2013; 10: 33-35
        • Tariq H.
        • Khan O.A.
        • Aftab M.T.
        Augmentation of oral submucous fibrosis by NSAIDS in the presence of risk factors.
        Pak J Pharm Sci. 2016; 29: 461-465
        • Shah D.J.
        • Chaudhari D.N.
        • Kharodia D.N.
        Scope of physiotherapy in oral medicine.
        J Govern Dent College Hosp. 2014; 01: 16-22
        • Koneru A.
        • Hunasgi S.
        • Hallikeri K.
        • et al.
        A systematic review of various treatment modalities for oral submucous fibrosis.
        J Adv Clin Res Insights. 2014; 1: 64-72
        • Málek J.
        • Ševčík P.
        • Bejšovec D.
        • et al.
        Postoperative pain management.
        Mladáfronta, Prague, Czech Republic2017: 91
        • Stanley T.H.
        The history and development of the fentanyl series.
        J Pain Symptom Manage. 1992; 7: S3-S7
        • Sloan P.A.
        • Moulin D.E.
        • Hays H.
        A clinical evaluation of transdermal therapeutic system fentanyl for the treatment of cancer pain.
        J Pain Symptom Manage. 1998; 16: 102-111
        • Ebrahimzadeh M.H.
        • Mousavi S.K.
        • Ashraf H.
        • et al.
        Transdermal fentanyl patches versus patient-controlled intravenous morphine analgesia for postoperative pain management.
        Iran Red Crescent Med J. 2014; 16: e11502
        • Lehmann L.J.
        • DeSio J.M.
        • Radvany T.
        • et al.
        Transdermal fentanyl in postoperative pain.
        Reg Anesth. 1997; 22: 24-28
        • Dhasmana S.
        • Singh V.
        • Pal U.S.
        Continuous ropivacaine infusion vs transdermal fentanyl for providing postoperative analgesia following temporomandibular joint interpositional gap arthroplasty.
        Natl J Maxillofac Surg. 2010; 1: 112-116
        • Todorovic V.-S.
        • Vasovic M.
        • Andric M.
        • et al.
        Efficacy of fentanyl transdermal patch in pain control after lower third molar surgery: a preliminary study.
        Med Oral Patol Oral Cir Bucal. 2016; 21: e621-e625
        • Shah A.F.
        • Baba I.A.
        • Saima S.
        Comparison of various surgical procedures used for treatment of oral submucous fibrosis.
        Int J Contemp Med Res. 2016; 3: 3086-3088
        • Lemeshow S.
        • Hosmer D.W.
        • Klar J.
        • et al.
        Adequacy of sample size in health studies.
        Wiley, 1990
        • Yeh C.J.
        Application of the buccal fat pad to the surgical treatment of oral submucous fibrosis.
        Int J Oral Maxillofac Surg. 1996; 25: 130-133
        • Tadakamadla J.
        • Kumar S.
        • Lalloo R.
        • et al.
        Development and validation of a quality-of-life questionnaire for patients with oral potentially malignant disorders.
        Oral Surg Oral Med Oral Pathol Oral Radiol. 2017; 123: 338-349
        • Thakur N.
        Effectiveness of micronutrients and physiotherapy in the management of oral submucous fibrosis.
        Int J Contemp Dent. 2011; 2: 101-105
        • Dani V.B.
        • Patel S.H.
        The effectiveness of therapeutic ultrasound in patients with oral submucosal fibrosis.
        Indian J Cancer. 2018; 55: 248-250
        • Kanjani V.
        • Annigeri R.G.
        • Revanappa M.M.
        Efficacy of spirulina with isometric exercises in the management of oral submucous fibrosis.
        J Adv Clin Res Insights. 2018; 5: 111-114
        • Moraes Ada R.
        • Sanches M.L.
        • Ribeiro E.C.
        • et al.
        Therapeutic exercises for the control of temporomandibular disorders.
        Dental Press J Orthod. 2013; 18: 134-139
        • Kale S.
        • Srivastava N.
        • Bagga V.
        • et al.
        Effectiveness of long term supervised and assisted physiotherapy in postsurgery oral submucous fibrosis patients.
        Case Rep Dent. 2016; 2016: 6081905
        • Aarabi S.
        • Longaker M.T.
        • Gurtner G.C.
        Hypertrophic scar formation following burns and trauma: new approaches to treatment.
        Plos Med. 2007; 4: e234
        • Grond S.
        • Radbruch L.
        • Lehmann K.A.
        Clinical pharmacokinetics of transdermal opiods: focus on transdermal fentanyl.
        Clin Pharmacokinet. 2000; 38: 59-89
        • Gan T.J.
        Poorly controlled postoperative pain: prevalence, consequences, and prevention.
        J Pain Res. 2017; 10: 2287-2298
        • Kehlet H.
        • Jensen T.S.
        • Woolf C.J.
        Persistent postsurgical pain: risk factors and prevention.
        Lancet. 2006; 367: 1618-1625
        • Bittencourt A.F.
        • Martins J.R.
        • Logullo L.
        • et al.
        Constipation is more frequent than diarrhea in patients fed exclusively by enteral nutrition.
        Nutr Clin Pract. 2012; 27: 533-539
        • Takeuchi K.
        Pathogenesis of NSAID-induced gastric damage: importance of cyclooxygenase inhibition and gastric hypermotility.
        World J Gastroenterol. 2012; 18: 2147-2160