Clinical Evaluation of Analgesic Efficacy and Safety of IV Nalbuphine versus IV Butorphanol in Patients Undergoing Tympanoplasty: A Randomised Clinical Study

Abstract

Introduction: Middle Ear Surgeries (MESs) are generally performed using local anaesthesia under sedation. Butorphanol and nalbuphine both are well-known synthetic opioid with agonist-antagonist characteristics. However, no reports present a direct comparison of the analgesic efficacy of these two drugs. Aim: To evaluate analgesic efficacy of intravenous butorphanol versus intravenous nalbuphine during Monitored Anaesthesia Care (MAC) in patients undergoing tympanoplasty. Materials and Methods: This randomised clinical trial was conducted at the Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Mumbai, Maharashtra India, from March 2018 to March 2021. Total 112 adult patients, undergoing tympanoplasty, were randomly allocated into two groups. Group N received 0.2 mg/kg nalbuphine intravenous (i.v.) and group B received i.v. 0.02 mg/ kg butorphanol. The patients were then evaluated for analgesic efficacy, sedation, blood pressure, Mean Arterial Pressure (MAP), Heart Rate (HR), Respiratory Rate (RR), blood oxygen levels (SpO2 ), Visual Analogue Scale (VAS) Score, need for intraoperative rescue sedation/analgesia, duration of action and side-effects. Results: A significant difference was observed in the patients’ responses to needle prick, where only 8 (13.3%) subjects gave a vocal response in group N versus 22 (36.6%) in group B. A significant difference in the mean time of onset of pain amongst both the group was recorded (3.16±1.38 hrs in group N and 2.63±1.19 hrs in group B). A significant difference was also recorded in the mean VAS at 15th (p-value=0.012) and 30th min (p-value= 0.017). Only 7 patients (11.6%) from group N, and 12 patients (20%) from group B required rescue agent (0.5 mcg/kg/ hour dexmedetomidine injection and 75 mg diclofenac sodium injection intravenous). Conclusion: Both 0.2 mg/kg nalbuphine and 0.2 mg/kg butorphanolprovide satisfactory results in terms of analgesic efficacy, sedation, hemodynamic and respiratory parameters, albeit, nalbuphine can be coined to be superior in terms of response to pin prick and duration of action.