title: Safety and efficacy of oral transmucosal fentanyl citrate compared to morphine sulphate immediate release tablet in management of breakthrough cancer pain.
abstract: OBJECTIVE
  To compare the efficacy and safety of oral transmucosal fentanyl citrate (OTFC) and oral morphine in Indian patients with breakthrough episodes of cancer pain.
  
  
  METHODS
  In this randomized, open label, active controlled, clinical study, total 186 patients who regularly experienced 1-4 episodes of breakthrough cancer pain (BTCP) daily, over the persistent pain controlled by taking oral morphine 60 mg/day or its equivalent were randomized to receive either OTFC 200 mcg or oral morphine 10 mg for the treatment of BTCP for 3 days. Improvement in pain as determined by numerical rating scale (NRS) at 5, 15, 30, and 60 minutes of drug administration and percentage of BTCP episodes showing reduction in pain intensity by >33% at 15 minutes were primary efficacy endpoints. Secondary efficacy endpoints were requirement for rescue analgesia and global assessment by physician and patient. Data of both treatment groups were analysed by appropriate statistical test using software, STATISTICA, version 11.
  
  
  RESULTS
  Patients treated with OTFC experienced significantly greater improvement in pain intensity of breakthrough episodes compared to those treated with oral morphine at all assessment time points (P < 0.0001). 56% of breakthrough pain episodes treated with OTFC showed a greater than 33% reduction in pain intensity from baseline at 15 minutes compared to 39% episodes treated with oral morphine (P < 0.0001). Patient's and physician's global assessment favoured OTFC than oral morphine (P < 0.0001). Requirement of rescue analgesia in both the study groups was similar (P > 0.05). Both study drugs were well tolerated.
  
  
  CONCLUSIONS
  OTFC was found to provide faster onset of analgesic effect than immediate release oral morphine in management of breakthrough cancer pain.
authors.affiliation: Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Sushma
authors.initials: S
authors.lastname: Bhatnagar
authors.affiliation: Department of Anesthetics and Pain Relief, Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India.
authors.forename: Saraswathi
authors.initials: S
authors.lastname: Devi
authors.affiliation: Department of Anesthesia and Pain Management, Rangadore Memorial Hospital, Shankarapuram, Bangalore, Karnataka, India.
authors.forename: Nk
authors.initials: N
authors.lastname: Vinod
authors.affiliation: Department of Anesthesia, Tata Memorial Center, Mumbai, Maharashtra, India.
authors.forename: Pn
authors.initials: P
authors.lastname: Jain
authors.affiliation: Department of Radiation Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, Andhra Pradesh, India.
authors.forename: G
authors.initials: G
authors.lastname: Durgaprasad
authors.affiliation: Department of Medical Services, Troikaa Pharmaceuticals Ltd, Ahemdabad, Gujarat, India.
authors.forename: Sanjaykumar H
authors.initials: SH
authors.lastname: Maroo
authors.affiliation: Department of Research and Development, Troikaa Pharmaceuticals Ltd, Ahmedabad, Gujarat, India.
authors.forename: Ketan R
authors.initials: KR
authors.lastname: Patel
keywords: Breakthrough cancer pain; Morphine; Numeric rating scale; Oral transmucosal fentanyl citrate