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用于外倒转术的氧化亚氮镇痛:一项随机对照试验。

Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.

作者信息

Straube Lacey E, Fardelmann Kristen L, Penwarden Amy A, Chen Fei, Harker Elsje, Redmon Benjamin F, Li Quefeng, Strauss Robert, Smith Kathleen A

机构信息

University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA.

University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA.

出版信息

J Clin Anesth. 2021 Feb;68:110073. doi: 10.1016/j.jclinane.2020.110073. Epub 2020 Oct 2.

Abstract

STUDY OBJECTIVE

Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.

DESIGN

Double-blinded randomized placebo-controlled trial.

SETTING

Labor and delivery triage room.

PATIENTS

Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.

INTERVENTIONS

Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.

MEASUREMENTS

The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.

MAIN RESULTS

Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI = -4.93, -0.34]; P = 0.025).

CONCLUSION

Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.

摘要

研究目的

我们的研究旨在确定在臀位外倒转术中,与氧气安慰剂相比,氧化亚氮镇痛是否能减轻疼痛。手术的成功可能会受到疼痛和焦虑的限制。尽管已经对这些手术广泛研究了神经轴麻醉,但许多中心缺乏常规使用的资源。氧化亚氮是非侵入性的,副作用极小,且所需设备有限。我们假设在臀位外倒转术中,与氧气安慰剂相比,其镇痛特性会减轻疼痛。

设计

双盲随机安慰剂对照试验。

地点

产房分诊室。

患者

48例年龄≥18岁、孕周37周及以上、单胎妊娠、臀位、美国麻醉医师协会身体状况I - III级且接受外倒转术的患者。

干预措施

接受外倒转术的患者被随机分为自我给予50%氧化亚氮/50%氧气组和100%氧气安慰剂组。

测量指标

主要测量指标是术中疼痛。次要指标是术中焦虑、患者满意度和手术难度。

主要结果

共纳入48例患者;23例接受氧化亚氮,25例接受氧气。平均疼痛评分(氧化亚氮5.5±2.3,安慰剂5.4±2.7,[可信区间=-1.40, 1.51];P = 0.943)或焦虑评分(氧化亚氮1.6±2.0,安慰剂1.2±1.8,[可信区间=-0.74, 1.45];P = 0.515)无差异。两组间手术难度(1 - 10分制,1 = 非常容易,10 = 极其困难)无差异(氧化亚氮6.1±2.2,安慰剂6.1±3.2,[可信区间=-1.54, 1.66];P = 0.944)。氧化亚氮组的倒转尝试次数显著增加(氧化亚氮3.9±1.9,安慰剂2.8±1.4,[可信区间=0.05, 2];P = 0.046)。氧化亚氮组患者满意度显著较低(氧化亚氮4.3±4.0,安慰剂6.9±3.6,[可信区间=-4.93, -0.34];P = 0.025)。

结论

尽管氧化亚氮有理想的特性,但在臀位外倒转术中,与氧气相比并无镇痛优势。不支持将其常规用于这些手术。

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