静脉注射氢吗啡酮滴定方案与常规治疗对老年急诊科急性疼痛管理的随机临床试验。
Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients.
机构信息
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY 10467, USA.
出版信息
Drugs Aging. 2013 Sep;30(9):747-54. doi: 10.1007/s40266-013-0103-y.
BACKGROUND AND OBJECTIVES
Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain.
METHODS
This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome.
RESULTS
83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone.
CONCLUSIONS
Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.
背景与目的
阿片类药物滴定是治疗疼痛的有效策略；然而，在繁忙的急诊部（ED）环境中，滴定通常是不切实际的。我们的目的是测试一种快速、两步、氢吗啡酮滴定方案，与老年患者在 ED 就诊时出现急性剧烈疼痛的常规治疗相比。
方法
这是一项针对 65 岁及以上、因急性剧烈疼痛到成人城市学术 ED 就诊的患者的前瞻性、随机临床试验。该研究在 http://www.clinicaltrials.gov 注册（NCT01429285）。随机分配到氢吗啡酮滴定方案的患者最初接受 0.5 mg 静脉注射氢吗啡酮。接受常规治疗的患者接受任何剂量的任何静脉内阿片类药物。在 15 分钟时，两组患者均被问及“您是否需要更多的止痛药？”回答“是”的氢吗啡酮滴定组患者接受第二剂 0.5 mg 静脉注射氢吗啡酮。回答“是”的常规治疗组患者将通知他们的 ED 主治医生，主治医生随后可以给予任何（或不给予）额外的药物。主要疗效结局是预先定义的满意镇痛，定义为在初始阿片类药物给药后 15 或 60 分钟时至少有一次患者拒绝额外镇痛。剂量以吗啡等效单位（MEU：1 mg 氢吗啡酮=7 mg 吗啡）计算。需要纳洛酮逆转阿片类药物不良反应是主要的安全结局。
结果
氢吗啡酮滴定组 153 例患者中有 83.0%达到满意镇痛，而常规治疗组 166 例患者中有 82.5%（p=0.91）。与常规治疗组相比，氢吗啡酮滴定组患者在基线时接受的初始阿片类药物平均剂量较低（分别为 3.5 MEU 和 4.7 MEU；p≤0.001），60 分钟内接受的总阿片类药物较少（分别为 5.3 MEU 和 6.0 MEU；p=0.03）。没有患者需要纳洛酮。
结论
0.5 mg 递增静脉注射氢吗啡酮的低剂量滴定与常规治疗相比，在 60 分钟内提供了相当的镇痛效果，而阿片类药物用量较少。
Zotero 插件