Pôle de Médecine d'Urgences, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Ann Emerg Med. 2010 Nov;56(5):509-16. doi: 10.1016/j.annemergmed.2010.03.020. Epub 2010 Apr 10.
We determine the best intravenous opioid titration protocol by comparing morphine and sufentanil for adult patients with severe traumatic acute pain in an out-of-hospital setting, with a physician providing care.
In this double-blind randomized clinical trial, patients were eligible for inclusion if aged 18 years or older, with acute severe pain (defined as a numeric rating scale score ≥ 6/10) caused by trauma. They were assigned to receive either intravenous 0.15 μg/kg sufentanil, followed by 0.075 μg/kg every 3 minutes or intravenous 0.15 mg/kg morphine and then 0.075 mg/kg. The primary endpoint of the study was pain relief at 15 minutes, defined as a numeric rating scale less than or equal to 3 of 10. Secondary endpoints were time to analgesia, adverse events, and duration of analgesia during the first 6 hours.
A total of 108 patients were included, 54 in each group. At 15 minutes, 74% of the patients in the sufentanil group had a numeric rating scale score of 3 or lower versus 70% of those in the morphine group (Δ4%; 95% confidence interval -13% to 21%). At 9 minutes, 65% of the patients in the sufentanil group experienced pain relief versus 46% of those in the morphine group (Δ18%; 95% confidence interval 0.1% to 35%). The duration of analgesia was in favor of the morphine group. Nineteen percent of patients experienced an adverse event in both groups, all mild to moderate.
Intravenous morphine titration using a loading dose of morphine followed by strictly administered lower doses at regular intervals remains the criterion standard. Moreover, this study supports the idea that the doses studied should be considered for routine administration in severe pain protocols.
我们通过比较在院外环境下,医生提供照护时,阿片类静脉药物(吗啡和舒芬太尼)在治疗成人严重创伤急性疼痛的效果,来确定最佳的静脉阿片类药物滴定方案。
在这项双盲随机临床试验中,纳入标准为年龄在 18 岁及以上、因创伤导致急性剧烈疼痛(定义为数字评分量表评分≥6/10)的患者。患者被随机分配接受静脉注射 0.15μg/kg 舒芬太尼,随后每 3 分钟给予 0.075μg/kg,或静脉注射 0.15mg/kg 吗啡,然后每 3 分钟给予 0.075mg/kg。该研究的主要终点是 15 分钟时的疼痛缓解程度,定义为数字评分量表评分≤3/10。次要终点为镇痛起效时间、不良事件以及首次 6 小时内的镇痛持续时间。
共纳入 108 例患者,每组 54 例。在 15 分钟时,舒芬太尼组中 74%的患者的数字评分量表评分为 3 或更低,而吗啡组中这一比例为 70%(差值 4%;95%置信区间-13%至 21%)。在 9 分钟时,舒芬太尼组中 65%的患者疼痛缓解,而吗啡组中这一比例为 46%(差值 18%;95%置信区间 0.1%至 35%)。镇痛持续时间有利于吗啡组。两组中均有 19%的患者出现不良事件,均为轻度至中度。
静脉注射吗啡时,先给予负荷剂量,然后严格每隔一定时间给予较低剂量,这种滴定方案仍然是标准方法。此外,本研究支持这样一种观点,即研究中所用的剂量应考虑纳入严重疼痛方案的常规给药。