Randomized Clinical Trial of the 2 mg Hydromorphone Bolus Protocol Versus the "1+1" Hydromorphone Titration Protocol in Treatment of Acute, Severe Pain in the First Hour of Emergency Department Presentation
Randomized Clinical Trial of the 2 mg Hydromorphone Bolus Protocol Versus the "1+1" Hydromorphone Titration Protocol in Treatment of Acute, Severe Pain in the First Hour of Emergency Department Presentation
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DOI：
10.1016/j.annemergmed.2013.02.023
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发表时间：
2013-10-01
影响因子：
6.2
通讯作者：
Gallagher, E. John
中科院分区：
文献类型：
--
作者：
Chang, Andrew K.;Bijur, Polly E.;Gallagher, E. John
研究目的：我们比较了高初始剂量静脉注射2mg氢吗啡酮与静脉滴注1mg氢吗啡酮之后可选的第二次剂量。方法：21 ~ 64岁重度疼痛患者随机分为单次静脉注射2 mg氢吗啡酮组和“1+1”氢吗啡酮滴定组。1+1患者接受1毫克静脉注射氢吗啡酮，15分钟后，如果他们回答“你还需要更多止痛药吗？”主要结果是在60分钟内拒绝额外镇痛的患者比例的组间差异。结果：在350例入组患者中，334例有足够的数据进行分析。2 mg剂量组拒绝使用额外镇痛药的比例为67.5%，1+1剂量组为67.3%（差异0.2%；95%可信区间为-9.7% ~ 10.2%）。数值评定量表疼痛评分的组间差异为0.4个数值评定量表单位（95%置信区间为-0.3 ~ 1.1）。不良反应的发生率相似；42.3%的1+1患者仅使用1 mg氢吗啡酮即可在1小时内获得满意的镇痛效果。结论：氢吗啡酮1+1滴定方案的镇痛效果与初始剂量2mg丸剂相似，后者没有明显的临床优势。1+1滴定方案具有阿片类药物节约效果，因为42.3%的患者需要减少50%的阿片类药物才能达到满意的镇痛效果。
Study objective: We compare a high initial dose of 2 mg intravenous hydromorphone against titration of 1 mg intravenous hydromorphone followed by an optional second dose.Methods: Patients aged 21 to 64 years with severe pain were randomly allocated to 2 mg intravenous hydromorphone in a single bolus or the "1+1" hydromorphone titration protocol. 1+1 Patients received 1 mg intravenous hydromorphone followed by a second 1 mg dose 15 minutes later if they answered yes when asked, Do you want more pain medication? The primary outcome was the between-group difference in proportion of patients who declined additional analgesia at 60 minutes.Results: Of the 350 enrolled patients, 334 had sufficient data for analysis. The proportion who declined additional analgesics was 67.5% in the 2 mg bolus arm and 67.3% in the 1+1 titration arm (difference 0.2%; 95% confidence interval -9.7% to 10.2%). The between-group difference in numeric rating scale pain scores was 0.4 numeric rating scale units (95% confidence interval -0.3 to 1.1). The incidence of adverse effects was similar; 42.3% of 1+1 patients achieved satisfactory analgesia at 1 hour with only 1 mg hydromorphone.Conclusion: A hydromorphone 1+1 titration protocol provides similar pain relief to an initial 2 mg bolus dose, with no apparent clinical advantage to the latter. The 1+1 titration protocol had an opioid-sparing effect because 50% less opioid was needed to achieve satisfactory analgesia for 42.3% of patients allocated to this protocol.