Pedersen Andreas Kristian, Nygaard Kevin Heebøll, Petersen Sofie Ronja, Specht Kirsten, Strøm Thomas, Moos Caroline Margaret, Skjøt-Arkil Helene, Schønnemann Jesper Ougaard
Department of Clinical Research, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark.
Department of Orthopedics, University Hospital of Southern Denmark, Kresten Phillipsens vej, Aabenraa, Denmark.
Contemp Clin Trials Commun. 2023 Nov 14;36:101228. doi: 10.1016/j.conctc.2023.101228. eCollection 2023 Dec.
The elderly population is expanding globally. This gives numerous challenges especially regarding hip fracture patients. In the US alone over 300.000 hip fracture patients are treated each year, and a large amount of those develop opoid addiction. Hip fractures require surgical intervention within 24 h and is associated with significant pain even at rest. Postoperative analgesic treatment need to be optimized to ensure adequate pain relief and to prevent subsequent opioid addiction. Previous studies have shown that methadone effectively decreases post-operative opioid consumption but the studies focused on younger patients undergoing elective surgery. This study focus on the use of methadone on the elderly, fragile patients undergoing acute surgery, by first determining the maximal tolerable dose.The hypothesis is the maximal tolerable doses of these hip-fracture patients lies between 0.10 mg/kg and 0.20 mg/kg. This trial aims to estimate the maximum tolerable dose of methadone when administered to elderly patients undergoing surgery for a hip fracture.
This project is an adaptive dose-finding trial. The continuous reassessment method will estimate the maximum tolerable dose of methadone. The primary outcome will be respiratory depression. The statistical analysis plan will be published a priori to the closure of patient recruitment and statistical analysis of database results.
The results of this study will give valuable information about the maximally tolerated dose of methadone for postoperative pain relief for elderly patients with hip fractures and potential adverse events.This trial is registered on clinicaltrials.gov with trial registration: NCT05581901. Registered 17 October 2022, https://www.clinicaltrials.gov/ct2/show/NCT05581901?term=methadone&cond = hip&draw = 2&rank = 1.
全球老年人口正在增加。这带来了诸多挑战，尤其是对于髋部骨折患者而言。仅在美国，每年就有超过30万名髋部骨折患者接受治疗，其中大量患者会出现阿片类药物成瘾。髋部骨折需要在24小时内进行手术干预，并且即使在休息时也会伴有严重疼痛。术后镇痛治疗需要优化，以确保充分缓解疼痛并预防随后的阿片类药物成瘾。先前的研究表明，美沙酮可有效减少术后阿片类药物的使用，但这些研究主要关注接受择期手术的年轻患者。本研究聚焦于美沙酮在接受急性手术的老年体弱患者中的应用，首先确定最大耐受剂量。假设是这些髋部骨折患者的最大耐受剂量在0.10mg/kg至0.20mg/kg之间。本试验旨在估计美沙酮用于接受髋部骨折手术的老年患者时的最大耐受剂量。
本项目是一项适应性剂量探索试验。连续重新评估法将用于估计美沙酮的最大耐受剂量。主要结局将是呼吸抑制。统计分析计划将在患者招募结束和数据库结果统计分析之前预先公布。
本研究结果将为髋部骨折老年患者术后疼痛缓解的美沙酮最大耐受剂量及潜在不良事件提供有价值的信息。本试验已在clinicaltrials.gov上注册，试验注册号：NCT05581901。于2022年10月17日注册，https://www.clinicaltrials.gov/ct2/show/NCT05581901?term=methadone&cond = hip&draw = 2&rank = 1 。
