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静脉注射对乙酰氨基酚不能减少急诊科患者使用吗啡缓解疼痛:一项多中心、随机、双盲、安慰剂对照试验。

Intravenous acetaminophen does not reduce morphine use for pain relief in emergency department patients: A multicenter, randomized, double-blind, placebo-controlled trial.

机构信息

Emergency Department, Cantonal Hospital of St. Gallen, St. Gallen, Switzerland.

Emergency Department, University Hospital Basel, University of Basel, Basel, Switzerland.

出版信息

Acad Emerg Med. 2022 Aug;29(8):954-962. doi: 10.1111/acem.14517. Epub 2022 May 22.

Abstract

BACKGROUND

Pain is one of the main reasons to present to emergency departments (EDs). Opioids are indispensable for acute pain management but are associated with side effects, misuse, and dependence. The aim of this study was to test whether a single dose of intravenous (IV) acetaminophen (paracetamol) can reduce the use of morphine for pain relief and/or morphine-related adverse events (AEs).

METHODS

ED patients >18 years with acute pain (i.e., Numeric Rating Scale [NRS] > 4) were screened for eligibility. Patients with analgesia in the past 6 h, chronic pain, or clinical instability were excluded. Patients were randomized in a 1:1 ratio to receive either morphine 0.1 mg/kg and 1 g acetaminophen IV or morphine 0.1 mg/kg and placebo IV. The intervention was double-blinded. Additional morphine 0.05 mg/kg IV was administered every 15 minutes until pain relief (defined as NRS < 4) and whether the pain recurred. The primary outcome was the mean morphine dose for pain relief. Secondary outcomes were the total amount of morphine given, time to achieve pain relief, and AEs.

RESULTS

A total of 220 patients were randomized and 202 evaluated for the primary outcome. The mean morphine dose for pain relief was similar in both groups (acetaminophen 0.15 mg ± 0.07 mg/kg, placebo 0.16 ± 0.07 mg/kg). There were no differences in the total amount of morphine given (acetaminophen 0.19 ± 0.09 mg/kg, placebo 0.19 ± 0.1 mg/kg), the time to achieve pain relief (acetaminophen 30 min [95% CI 17-31 min], placebo 30 min [95% CI 30-35 min]), and the frequency of AEs (overall 27.4%). Time to pain recurrence did not differ significantly between the groups (hazard ratio 1.23 [0.76-1.98], p = 0.40).

CONCLUSIONS

In ED patients, acetaminophen had no additional effect on pain control or morphine-sparing effect at the time of first morphine administration. Titrated morphine with the algorithm used was highly effective, with 80% of all patients reporting pain relief within 60 min of starting therapy.

摘要

背景

疼痛是前往急诊部(ED)的主要原因之一。阿片类药物对于急性疼痛管理是不可或缺的,但会引起副作用、滥用和依赖。本研究的目的是检验静脉注射(IV)扑热息痛(对乙酰氨基酚)单次剂量是否可以减少吗啡的使用以缓解疼痛和/或减少与吗啡相关的不良事件(AE)。

方法

筛选出年龄大于 18 岁、有急性疼痛(即 NRS>4)的 ED 患者,纳入标准为 NRS>4 分,排除标准为过去 6 小时内使用过镇痛剂、慢性疼痛或临床不稳定的患者。患者以 1:1 的比例随机分为两组,分别接受吗啡 0.1mg/kg 联合 1g 扑热息痛 IV 或吗啡 0.1mg/kg 联合安慰剂 IV。干预措施为双盲。每隔 15 分钟给予患者 0.05mg/kg 的额外吗啡 IV,直到疼痛缓解(定义为 NRS<4)以及疼痛是否再次出现。主要结局为缓解疼痛所需的平均吗啡剂量。次要结局为所用吗啡总量、达到疼痛缓解的时间以及 AE。

结果

共有 220 名患者被随机分组,202 名患者接受了主要结局评估。两组缓解疼痛所需的吗啡平均剂量相似(扑热息痛组 0.15mg±0.07mg/kg,安慰剂组 0.16mg±0.07mg/kg)。两组吗啡总用量(扑热息痛组 0.19mg±0.09mg/kg,安慰剂组 0.19mg±0.1mg/kg)、达到疼痛缓解的时间(扑热息痛组 30 分钟[95%CI 17-31 分钟],安慰剂组 30 分钟[95%CI 30-35 分钟])和 AE 发生率(总体 27.4%)均无显著差异。两组疼痛复发时间无显著差异(风险比 1.23[0.76-1.98],p=0.40)。

结论

在 ED 患者中,首次给予吗啡时,扑热息痛对疼痛控制或吗啡节省效果没有额外作用。使用该算法滴定吗啡非常有效,所有患者中有 80%在开始治疗后 60 分钟内报告疼痛缓解。

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