Evaluation Of The Efficacy And Safety Of Butorphanol Nasal Spray In The Management Of Postoperative Pain

摘要

Objective: To evaluate the efficacy and safety of Butorphanol nasal spray in the management of postoperative pain in patients with orthopedic surgery. Materials and Methods: This prospective, open and non-comparative study was conducted on outpatient basis by qualified investigators at three different centers. A total of 105 patients with postoperative pain were enrolled in the study. The enrollment of the patients was as per inclusion/exclusion criteria. After obtaining informed consent they were individually interviewed, examined, investigated and treated as per study protocol. The treatment included one dose of Butorphanol nasal spray in each nostril equivalent to 2 mg of Butorphanol for the period of 24 hours. They were followed up at the end of 1 hour, 2, 4, 6, 12 and 24 hours. They were asked to avoid any other concomitant medication without the knowledge of the treating physician. Results: A significant improvement in the pain score of the patients was observed at the end of 15 min. The treatment with Butorphanol nasal spray is associated with very few adverse events. Tolerability of the treatment was also reported to be excellent in the majority of the study population. Nasal administration with faster absorption offers advantages of rapid onset and patient control with relative ease of administration. It bypasses gastrointestinal and hepatic presystemic elimination and is also applicable in patients with nausea and vomiting. Conclusion: The present study concludes that Butorphanol nasal spray is highly effective, safe and well tolerable in postoperative pain management and seems to be a good alternative to both oral and injectable Butorphanol treatment. Introduction Pain is as old as human being and is becoming more and more troublesome to mankind with greater incidences of medical surgeries. Many surgical procedures are associated with extreme painful conditions which are associated with physical, psychological and immunological depression. The field of postoperative pain management is being given more and more attention as it is an essential component of the care of surgical patients. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. The overriding principle of postoperative pain management is to provide a general background of analgesia that is sufficient to permit normal activities, along with additional analgesic supplements to cover any painful activity (dynamic pain). Breaking the pain cycle at an early stage may prevent central sensitization and, consequently, chronic pain. A second objective is to improve surgical outcome with the goals of enabling early ambulation and recovery of gastrointestinal function which in turn reduce cardiopulmonary morbidity, psychological stress, anxiety and insomnia; and preventing a poor learned response to future pain episodes.A wide area of postoperative pain management is covered by afferent neural blockade with local anesthetics. Next in order of effectiveness are high dose opioids, epidural opioids and clonidine, patient controlled opioid therapy and Non-Steroidal Anti-Inflammatory Agents.Butorphanol is a synthetic opioid derivative possessing agonist-antagonist activity at opioid μ2-receptors and additional agonist activity at opioid κ-receptors. The analgesic efficacy of Butorphanol is comparable with that of Morphine, Mepiridine, and other opioids. However, the safety concerns with Butorphanol are much lower compared to other opioids, especially the addiction potential. The 14 years of safe and effective use of Butorphanol injection make Butorphanol the ‘drug of choice' in a number of painful conditions.In recent years, nasal drug delivery systems emerged as a suitable alternative for the common route of intravenous and oral dosing. Nasal administration may offer advantages such as ease of administration, rapid onset and patient control. It bypasses gastrointestinal and hepatic presystemic elimination and is applicable in