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口服与静脉注射对乙酰氨基酚用于术后疼痛控制的随机试验。

Randomized trial of oral versus intravenous acetaminophen for postoperative pain control.

作者信息

Hickman Skip R, Mathieson Kathleen M, Bradford Lynne M, Garman Casey D, Gregg Richard W, Lukens Douglas W

机构信息

Kettering Health Network, Miamisburg, OH

College of Graduate Health Studies, A. T. Still University, Mesa, AZ.

出版信息

Am J Health Syst Pharm. 2018 Mar 15;75(6):367-375. doi: 10.2146/ajhp170064.

Abstract

PURPOSE

Results of a study comparing pain control outcomes with preoperative oral versus intraoperative i.v. acetaminophen use in adults undergoing total hip or knee arthroplasty are reported.

METHODS

A single-center, randomized, placebo-controlled, equivalence trial was conducted. Patients were assigned (1:1) to receive 2 500-mg capsules of acetaminophen before surgery, with an i.v. placebo infusion during surgery (the oral group), or 2 oral placebo capsules followed by an i.v. infusion of acetaminophen 1,000 mg/100 mL (the i.v. group). Patients were followed after postanesthesia care unit (PACU) admission up to 24 hours postoperatively.

RESULTS

Among 486 patients included in a modified intention-to-treat analysis (mean ± S.D. age, 66.3 ± 9.4 years), there were no significant differences in preoperative and intraoperative use of pain medication between the oral and i.v. groups. Postoperative opioid use in morphine milligram equivalents (MMEs) was equivalent in the oral and i.v. groups (i.e., the mean difference in median MME values was within the prespecified equivalence margin), with no significant between-group differences in mean pain scores over 24 hours.

CONCLUSION

In patients undergoing hip or knee arthroplasty, oral acetaminophen given preoperatively was equivalent to i.v. acetaminophen administered in the operating suite in controlling pain in the immediate postoperative period. I.V. acetaminophen was not superior to oral acetaminophen in reducing postoperative nausea and vomiting, time to ambulation, time to first dose of as-needed pain medication, length of PACU stay, or total length of hospital stay.

摘要

目的

报告一项关于在接受全髋关节或膝关节置换术的成人中,比较术前口服对乙酰氨基酚与术中静脉注射对乙酰氨基酚的疼痛控制效果的研究结果。

方法

进行了一项单中心、随机、安慰剂对照、等效性试验。患者被随机(1:1)分配,一组在手术前接受2粒500毫克对乙酰氨基酚胶囊,术中接受静脉注射安慰剂(口服组);另一组接受2粒口服安慰剂胶囊,随后静脉注射1000毫克/100毫升对乙酰氨基酚(静脉注射组)。患者在进入麻醉后护理单元(PACU)后接受随访,直至术后24小时。

结果

在纳入改良意向性分析的486例患者中(平均±标准差年龄,66.3±9.4岁),口服组和静脉注射组在术前和术中使用止痛药物方面无显著差异。口服组和静脉注射组术后阿片类药物使用的吗啡毫克当量(MME)相当(即MME中位数的平均差异在预先设定的等效范围内),两组在24小时内的平均疼痛评分无显著组间差异。

结论

在接受髋关节或膝关节置换术的患者中,术前口服对乙酰氨基酚在术后即刻控制疼痛方面与在手术室静脉注射对乙酰氨基酚等效。在减少术后恶心呕吐、下床活动时间、首次按需使用止痛药物的时间、PACU停留时间或住院总时长方面,静脉注射对乙酰氨基酚并不优于口服对乙酰氨基酚。

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