ORIGINAL ARTICLE The efficacy of oral piroxicam fast-dissolving tablets versus sublingual fentanyl in incident breakthrough pain due to bone metastases: a double-blinded randomized study Ayman Abdalmaksoud Yousef 1 & Ashraf Elsayed Alzeftawy 1 Received: 17 November 2017 /Accepted: 10 September 2018 # Springer-Verlag GmbH Germany, part of Springer Nature 2018 Abstract Purpose Breakthrough pain (BTP) is a transient exacerbation of pain occurring in a patient with chronic, persistent pain. The most common type is incident pain that is mostly related to bone metastases. The oral mucosa is an attractive route for drug delivery. Sublingual fentanyl preparations are a very attractive agent in controlling attacks of BTP due to its rapid absorption through the oral mucosa. Non-steroidal anti-inflammatory drugs (NSAIDs) play a key role as a first step in treatment of cancer pain; piroxicam sublingual formulations could be a useful alternative in controlling incident pain. Our study hypothesis is to evaluate the efficacy of sublingual fentanyl versus oral piroxicam fast-dissolving tablets in patients with incident pain and its impact on functional status. Patients and methods A cohort of 100 adults of both genders suffering from bone metastases. Patients were assigned to receive either sublingual fentanyl tablet (group 1) or oral piroxicam fast-dissolving tablets (group 2). The pain intensity reduction on a 0– 10 visual analog scale (VAS), frequency of BTP attacks, and onset of pain relief. Secondary end points included the functional interference items of the Brief Pain Inventory (BPI). Results There is no significant difference between the two groups regarding the patients’ demographics. Significant decline of the VAS in each group in comparison to the pretreatment values (p = 0.001). Non-significant changes of the VAS, duration of pain attacks, and number of rescue doses in comparing both groups were measured. There was significant reduction in group 2 BPI regarding the relation with others, sleep pattern and enjoyment of life parameters at 2 and 4 weeks (p = 0.001). Conclusion Our study demonstrated that oral piroxicam fast-dissolving tablet is an analgesic alternative to sublingual fentanyl in patients with bone metastasis to control incidental BTP attacks with more favorable cost-benefit values. Keywords Oral piroxicam tablets . Sublingual fentanyl . Incident BTP . Bone metastases Introduction The term of breakthrough pain (BTP) is considered as tran- sient exacerbation of pain in patients with persistent chronic pain. It affects more than 60% of cancer patients, particularly those with moderate to severe chronic pain. It is a resistant type of pain syndromes for management. There are multiple forms of BTP cancer pain [1]. The most common type of BTP in cancer patients is incident pain that is mostly related to bone metastases [2]. The oral mucosa is an attractive route for drug delivery as it is generally associated with more rapid absorption compared with the oral route [3]. Fentanyl is a highly lipophilic opioid and, when placed in saliva under normal oral conditions, 80% of the administered dose remains non-ionized allowing the drug to pass readily through the buccal mucosa, quickly cross the blood–brain barrier, and enter the central nervous system [4]. Poor economy, relatively high cost of rapidly acting opioid in developing countries, in addition to lack of pharmacoeconomic studies assessing the net benefit of different formulation of rap- idly acting opioid, directed the health care directors to seek alter- native measures to control BTP attacks at relatively low cost with nearly similar efficacy to sublingual rapidly acting opioid [5, 6]. * Ayman Abdalmaksoud Yousef ayman.yousef@rocketmail.com 1 Pain Unit, Anesthesia Department, Faculty of Medicine, Tanta University, 7 Moheb street, Tanta, Egypt Supportive Care in Cancer https://doi.org/10.1007/s00520-018-4469-6