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在孕早期人工流产期间,使用给药算法的静脉镇静与标准护理的随机对照比较。

A randomized comparison of intravenous sedation using a dosing algorithm compared to standard care during first-trimester surgical abortion.

作者信息

Braaten Kari P, Urman Richard D, Maurer Rie, Fortin Jennifer, Goldberg Alisa B

机构信息

Planned Parenthood League of Massachusetts, 1055 Commonwealth Ave, Boston, MA 02215, USA; Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital, 1620 Tremont St, Boston, MA 02120, USA.

Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.

出版信息

Contraception. 2018 Jun;97(6):490-496. doi: 10.1016/j.contraception.2018.01.013. Epub 2018 Feb 2.

Abstract

OBJECTIVE

The objective was to compare the safety and efficacy of an algorithm for abortion intravenous sedation dosing (AAID) to standard dosing during first-trimester surgical abortion.

STUDY DESIGN

This was a randomized, single-blinded, controlled trial in which women undergoing first-trimester surgical abortion received fentanyl and midazolam dosed per either an algorithm or clinic standard. Patient-level factors including weight, airway risk, anxiety, and drug and alcohol use determined AAID doses. The primary outcome was pain with suction curettage measured immediately on a 21-point verbal numerical rating scale ranging from 0 to 100. Secondary outcomes included pain with cervical dilation and postprocedure, intraoperative pain as recalled postprocedure, need for additional doses of medication, oxygen saturation<93%, sedation level, adverse events, side effects and patient satisfaction.

RESULTS

We enrolled 196 women and randomized 98 to the AAID and 98 to standard care. Baseline factors were similar between groups. Median intraoperative pain scores did not differ between groups when measured immediately (47.5 vs. 50, p=.81) or on recall (30 in both arms, p=.68). There were no significant differences in other secondary outcomes. Women with a body mass index (BMI) 30-35 trended toward improved pain control with the algorithm (60 vs. 27.5, p=.07).

CONCLUSIONS

Intravenous sedation determined by an algorithm did not produce differences in pain scores in a setting with highly experienced providers.

IMPLICATIONS

An intravenous sedation algorithm did not demonstrate significant benefit for the general population of surgical abortion patients. Providers with less experience titrating intravenous sedation might find it a helpful tool to guide sedation dosing. A possible benefit in obese patients warrants further study.

摘要

目的

比较妊娠早期手术流产时流产静脉镇静给药算法(AAID)与标准给药的安全性和有效性。

研究设计

这是一项随机、单盲、对照试验,接受妊娠早期手术流产的女性按算法或临床标准接受芬太尼和咪达唑仑给药。包括体重、气道风险、焦虑以及药物和酒精使用情况等患者层面因素决定AAID剂量。主要结局是在21点言语数字评定量表(范围为0至100)上立即测量的吸宫刮宫时的疼痛。次要结局包括宫颈扩张时和术后的疼痛、术后回忆的术中疼痛、额外药物剂量需求、氧饱和度<93%、镇静水平、不良事件、副作用和患者满意度。

结果

我们纳入了196名女性,随机将98名分配至AAID组,98名分配至标准治疗组。两组间基线因素相似。立即测量时,两组间术中疼痛评分中位数无差异(47.5对50,p = 0.81),术后回忆时也无差异(两组均为30,p = 0.68)。其他次要结局无显著差异。体重指数(BMI)为30 - 35的女性使用该算法时疼痛控制有改善趋势(60对27.5,p = 0.07)。

结论

在有经验丰富的医护人员的情况下,由算法确定的静脉镇静在疼痛评分上未产生差异。

启示

静脉镇静算法对手术流产患者总体人群未显示出显著益处。经验较少的静脉镇静滴定医护人员可能会发现它是指导镇静给药的有用工具。肥胖患者可能存在的益处值得进一步研究。

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