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吗啡与芬太尼用于剖宫产术后脊髓镇痛的随机对照试验

Morphine versus fentanyl for spinal post-caesarean analgesia: a randomised controlled trial.

作者信息

El Aish Khaled Abu, Tafish Raed, Zourob Haly

机构信息

Pharmacy Department, Al Helal Al Emirati Hospital, Ministry of Health, Rafah, Gaza Strip, occupied Palestinian territory.

Anaesthesia Department, Al Helal Al Emirati Hospital, Ministry of Health, Rafah, Gaza Strip, occupied Palestinian territory.

出版信息

Lancet. 2018 Feb 21;391 Suppl 2:S20. doi: 10.1016/S0140-6736(18)30386-6.

Abstract

BACKGROUND

Finding appropriate analgesics is important for a mother's recovery after a caesarean section. The aim of this study was to compare the analgesic effect of spinal morphine and fentanyl for women undergoing a caesarean section.

METHODS

In this randomised, unmasked, parallel-group, controlled trial, eligible participants were women undergoing caesarean section with spinal anaesthetic at the Al-Helal Al-Emirati Hospital, Rafah, Gaza Strip, occupied Palestinian territory. Using a manually generated allocation sequence that was independently managed by medical staff, we randomly assigned women (1:1) to receive either 0·2 mg preservative-free morphine or 20 μg fentanyl, spinally, combined with 2 mL of 0·5% hyperbaric bupivacaine for spinal anaesthesia. Pain was recorded by visual analogue scales (VAS; range 0-10, where 0 means no pain and 10 means pain is intolerable) at 1 h, 6 h, 12 h, 18 h, and 24 h after the caesarean section. Time and amount of other analgesics needed were recorded (primary outcome). Secondary outcomes were nausea-vomiting scores (NVS 0-3, where 0 means no nausea or vomiting and 3 means severe nausea or vomiting that is unresponsive to antiemetics), and pruritus scores (PS 0-2, where 0 means no pruritus and 2 means severe pruritus). Data were analysed with SPSS. We compared outcomes using Mann-Whitney U-test, student's t-test, OR, or χ test. The study was approved by the ministry of health and the Helsinki Committee, Gaza Strip. Women provided verbal informed consent before participation.

FINDINGS

We enrolled 121 women (mean age 28·43 years [SD 5·62]). 59 women were randomly assigned to the morphine group, and 62 women were randomly assigned to the fentanyl group. Pain was reduced with morphine compared with fentanyl at 1 h (VAS score: 1·81 for morphine vs 2·57 for fentanyl; p<0·039), at 6 h (1·84 vs 5·08; p<0·0001), at 12 h (1·45 vs 3·30; p<0·0001), at 18 h (1·62 vs 3·18; p<0·0001), and at 24 h (1·61 vs 2·68; p=0.0001). The time to needing other analgesic drug was longer in the morphine group than in the fentanyl group (9·03 h vs 2·46 h; p<0·0001). 20 (34%) women in the morphine group did not need analgesics, whereas all (100%) women with fentanyl needed additional analgesics (odds ratio [OR] 2·59, 95% CI 2·03-3·31). Mild nausea and drowsiness were seen more in the morphine group than in the fentanyl group at 6 h and 12 h, respectively (p=0·010). Nine (15%) women in the morphine group had pruritus and needed treatment compared with one (2%) woman in the fentanyl group (OR 10·98, 95% CI 1·35-89·62).

INTERPRETATION

Spinal morphine was more effective than spinal fentanyl for caesarean analgesia. Morphine was associated with more side-effects than fentayl, but these were treatable and did not pose any danger to women.

FUNDING

None.

摘要

背景

找到合适的镇痛药对剖宫产术后母亲的恢复很重要。本研究的目的是比较脊髓注射吗啡和芬太尼对剖宫产女性的镇痛效果。

方法

在这项随机、非盲、平行组对照试验中,符合条件的参与者是在巴勒斯坦被占领土加沙地带拉法的Al-Helal Al-Emirati医院接受脊髓麻醉剖宫产的女性。我们使用由医务人员独立管理的手动生成的分配序列,将女性(1:1)随机分配接受0.2 mg无防腐剂吗啡或20 μg芬太尼脊髓注射,并与2 mL 0.5%高压布比卡因联合用于脊髓麻醉。剖宫产术后1小时、6小时、12小时、18小时和24小时,通过视觉模拟量表(VAS;范围0-10,其中0表示无疼痛,10表示疼痛无法忍受)记录疼痛情况。记录所需其他镇痛药的时间和剂量(主要结局)。次要结局是恶心呕吐评分(NVS 0-3,其中0表示无恶心或呕吐,3表示严重恶心或呕吐且对抗呕吐药无反应)和瘙痒评分(PS 0-2,其中0表示无瘙痒,2表示严重瘙痒)。数据用SPSS分析。我们使用曼-惠特尼U检验、学生t检验、OR或χ检验比较结局。该研究得到了卫生部和加沙地带赫尔辛基委员会的批准。女性在参与前提供了口头知情同意。

结果

我们纳入了121名女性(平均年龄28.43岁[标准差5.62])。59名女性被随机分配到吗啡组,62名女性被随机分配到芬太尼组。在剖宫产术后1小时(VAS评分:吗啡组为1.81,芬太尼组为2.57;p<0.039)、6小时(1.84对5.08;p<0.0001)、12小时(1.45对3.30;p<0.0001)、18小时(1.62对3.18;p<0.0001)和24小时(1.61对2.68;p = 0.0001),吗啡组的疼痛程度低于芬太尼组。吗啡组需要其他镇痛药的时间比芬太尼组长(9.03小时对2.46小时;p<0.0001)。吗啡组20名(34%)女性不需要镇痛药,而芬太尼组所有(100%)女性都需要额外的镇痛药(比值比[OR]2.59,95%置信区间2.03-3.31)。分别在6小时和12小时,吗啡组轻度恶心和嗜睡的发生率高于芬太尼组(p = 0.010)。吗啡组9名(15%)女性出现瘙痒并需要治疗,而芬太尼组1名(2%)女性出现瘙痒(OR 10.98,95%置信区间1.35-89.62)。

解读

脊髓注射吗啡在剖宫产镇痛方面比脊髓注射芬太尼更有效。吗啡比芬太尼有更多的副作用,但这些副作用是可治疗的,对女性没有任何危险。

资金来源

无。

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