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静脉注射对乙酰氨基酚用于幕上开颅术后疼痛:一项前瞻性、随机、双盲、安慰剂对照试验。

Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial.

机构信息

Departments of1Neurosurgery and.

3Neurosciences Clinical Program, Intermountain Healthcare, Murray.

出版信息

J Neurosurg. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.

DOI:10.3171/2017.10.JNS171464
PMID:29676689
Abstract

OBJECTIVE

Acute pain control after cranial surgery is challenging. Prior research has shown that patients experience inadequate pain control post-craniotomy. The use of oral medications is sometimes delayed because of postoperative nausea, and the use of narcotics can impair the evaluation of brain function and thus are used judiciously. Few nonnarcotic intravenous (IV) analgesics exist. The authors present the results of the first prospective study evaluating the use of IV acetaminophen in patients after elective craniotomy.

METHODS

The authors conducted a randomized, double-blinded, placebo-controlled investigation. Adults undergoing elective, supratentorial craniotomies between September 2013 and June 2015 were randomized into two groups. The experimental group received 1000 mg/100 ml IV acetaminophen every 8 hours for 48 hours. The placebo group received 100 ml of 0.9% normal saline on the same schedule. Both groups were also treated with a standardized pain control algorithm. The study was powered to detect a 30% difference in the primary outcome measures: narcotic consumption (morphine equivalents, ME) at 24 and 48 hours after surgery. Patient-reported pain scores immediately postoperatively and 48 hours after surgery were also recorded.

RESULTS

A total of 204 patients completed the trial. No significant differences were found in narcotic consumption between groups at either time point (in the treatment and placebo groups, respectively, at 24 hours: 84.3 ME [95% CI 70.2–98.4] and 85.5 ME [95% CI 73–97.9]; and at 48 hours: 123.5 ME [95% CI 102.9–144.2] and 134.2 ME [95% CI 112.1–156.3]). The difference in improvement in patient-reported pain scores between the treatment and placebo groups was significant (p < 0.001).

CONCLUSIONS

Patients who received postoperative IV acetaminophen after craniotomy did not have significantly decreased narcotic consumption but did experience significantly lower pain scores after surgery. The drug was well tolerated and safe in this patient population.

摘要

目的

颅脑手术后急性疼痛的控制具有挑战性。既往研究表明,患者在颅后手术中经历了不足的疼痛控制。由于术后恶心,口服药物的使用有时会延迟,而麻醉性镇痛药会损害脑功能的评估,因此需要谨慎使用。目前存在的非麻醉性静脉(IV)镇痛药较少。作者介绍了首次评估择期颅手术后使用 IV 对乙酰氨基酚的前瞻性研究结果。

方法

作者进行了一项随机、双盲、安慰剂对照研究。2013 年 9 月至 2015 年 6 月期间接受择期幕上开颅手术的成年人被随机分为两组。实验组每 8 小时接受 1000mg/100ml IV 对乙酰氨基酚,共 48 小时。对照组在相同的时间间隔内接受 100ml 生理盐水。两组均采用标准化疼痛控制算法治疗。该研究的目的是检测 24 和 48 小时后主要结局测量(吗啡等效物,ME)的 30%差异。还记录了术后即刻和术后 48 小时的患者报告疼痛评分。

结果

共有 204 例患者完成了试验。两组在任何时间点的阿片类药物消耗量均无显著差异(分别在治疗组和安慰剂组,在 24 小时时:84.3ME[95%CI 70.2-98.4]和 85.5ME[95%CI 73-97.9];48 小时时:123.5ME[95%CI 102.9-144.2]和 134.2ME[95%CI 112.1-156.3])。治疗组和安慰剂组患者报告疼痛评分的改善差异有统计学意义(p<0.001)。

结论

颅后手术接受术后 IV 对乙酰氨基酚的患者阿片类药物消耗量没有显著减少,但术后疼痛评分明显降低。该药在该患者人群中耐受良好且安全。

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