Bøndergaard Michael, Uhrbrand Peter Gaarsdal, Karaca Tutku, Rhode Marianne, Kjærgaard Thomas, Svendsen Rene Thunberg, Klug Tejs Ehlers, Nikolajsen Lone, Friesgaard Kristian Dahl
Department of Anaesthesiology and Intensive Care, Randers Regional Hospital, Randers, Denmark.
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
BJA Open. 2025 May 26;14:100418. doi: 10.1016/j.bjao.2025.100418. eCollection 2025 Jun.
Tonsillectomy is a common procedure often associated with severe postoperative pain. This study hypothesised that methadone would provide superior postoperative pain relief and reduced opioid consumption compared with fentanyl.
A total of 120 adult patients undergoing elective bilateral tonsillectomy were randomly allocated to receive either methadone (0.2 mg kg; =62) or fentanyl (3 μg kg; =58) after anaesthesia induction. Joint primary outcomes were pain intensity (numeric rating scale, 0-10) at swallowing upon postanaesthesia care unit (PACU) arrival and cumulative opioid consumption (oral morphine equivalents) over 5 postoperative days. Secondary outcomes included pain at swallowing, PACU and hospital stay duration, sedation at 4 h, patient satisfaction at days 1 and 7, postoperative nausea/vomiting (PONV) on days 1-3, and PACU adverse events.
Cumulative 5-day opioid consumption was lower in the methadone group (30 mg, inter-quartile range [IQR] 10-50 mg) the fentanyl group (49 mg, IQR 29-80 mg, =0.002), driven by reduced use on day 1. Pain intensity was lower in the methadone group compared with the fentanyl group in the PACU (4, IQR 3-5 5, IQR 4-7, =0.0004), at 24 h (=0.005) and 48 h (=0.03). More patients in the methadone group experienced moderate to severe PONV at 24 h (45.0%, 14.1%, =0.001), 48 h (43.3% 17.6%, =0.005), and 72 h (33.9% 18.2%, =0.03). Secondary outcomes, including patient satisfaction, sedation, and discharge times, did not differ significantly.
Methadone reduced opioid consumption and pain intensity but increased PONV. Identifying risk factors for both severe postoperative pain and PONV may help guide patient selection for methadone use.
NCT05445856, EudraCT ID 2022-002496-11.
扁桃体切除术是一种常见手术，术后常伴有严重疼痛。本研究假设，与芬太尼相比，美沙酮能提供更好的术后疼痛缓解效果，并减少阿片类药物的用量。
总共120例接受择期双侧扁桃体切除术的成年患者在麻醉诱导后被随机分配接受美沙酮（0.2毫克/千克；n = 62）或芬太尼（3微克/千克；n = 58）。联合主要结局指标为麻醉后护理单元（PACU）到达时吞咽时的疼痛强度（数字评分量表，0 - 10）以及术后5天内阿片类药物的累积用量（口服吗啡当量）。次要结局指标包括吞咽时的疼痛、PACU停留时间和住院时间、4小时时的镇静情况、第1天和第7天的患者满意度、第1 - 3天的术后恶心/呕吐（PONV）以及PACU不良事件。
美沙酮组5天阿片类药物累积用量较低（30毫克，四分位间距[IQR] 10 - 50毫克），低于芬太尼组（49毫克，IQR 29 - 80毫克，P = 0.002），这是由于第1天用量减少所致。在PACU中，美沙酮组的疼痛强度低于芬太尼组（4，IQR 3 - 5 对 5，IQR 4 - 7，P = 0.0004），在24小时时（P = 0.005）和48小时时（P = 0.03）也是如此。美沙酮组更多患者在24小时（45.0% 对 14.1%，P = 0.001）、48小时（43.3% 对 17.6%，P = 0.005）和72小时（33.9% 对 18.2%，P = 0.03）经历了中度至重度PONV。包括患者满意度、镇静情况和出院时间在内的次要结局指标无显著差异。
美沙酮减少了阿片类药物用量和疼痛强度，但增加了PONV的发生率。识别术后严重疼痛和PONV的风险因素可能有助于指导美沙酮使用的患者选择。
NCT05445856，欧盟临床试验注册号2022 - 002496 - 11。
