Zuarez-Easton Sivan, Zafran Noah, Garmi Gali, Dagilayske Dorit, Inbar Shiri, Salim Raed
Department of Obstetrics and Gynecology, Emek Medical Center, Afula, and the Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.
Obstet Gynecol. 2023 Jan 1;141(1):4-10. doi: 10.1097/AOG.0000000000005011. Epub 2022 Dec 2.
To compare the efficacy and adverse effects of intravenous meperidine and inhaled nitrous oxide for intrapartum analgesia in multiparous patients.
This randomized controlled trial was conducted in the delivery ward of a university teaching medical center in Afula, Israel. Multiparous patients with term, singleton pregnancies who were in labor were randomized in a 1:1 ratio to 50 mg intravenous meperidine or inhaled nitrous oxide. The primary outcome was pain intensity 20-30 minutes after analgesic administration, measured on a visual analog scale (VAS) from 0 to 10 cm. Secondary outcomes included the need for additional analgesia, labor length, delivery mode, patient satisfaction, and maternal and neonatal adverse effects. To detect a 1-cm (±2.6) difference in VAS score between the groups, 214 total participants were needed to achieve 80% power with an alpha of 0.05.
From August 2016 through May 2019, 214 participants were enrolled. Fourteen were excluded after randomization. Of the 200 analyzed, 102 received nitrous oxide, and 98 received intravenous meperidine. Demographic and obstetric variables were comparable between the two groups. The VAS score 20-30 minutes after analgesic administration did not differ between the groups (7.7±2.3 cm and 7.6±2.7 cm in the nitrous oxide and meperidine groups, respectively, P=.89). There were no significant differences between the groups in the rate of additional analgesic use, labor length, delivery mode, Apgar scores, rate of breastfeeding, patient satisfaction, or maternal and neonatal adverse effects.
Pain intensity was comparable in multiparous patients 20-30 minutes after administration of meperidine and nitrous oxide. Adverse effects were also comparable.
ClinicalTrials.gov, NCT02783508.
比较静脉注射哌替啶和吸入氧化亚氮用于经产妇分娩期镇痛的疗效及不良反应。
本随机对照试验在以色列阿富拉一所大学教学医疗中心的产房进行。将足月、单胎妊娠且处于分娩期的经产妇按1:1比例随机分为静脉注射50mg哌替啶组或吸入氧化亚氮组。主要结局指标为镇痛给药后20 - 30分钟的疼痛强度,采用0至10厘米的视觉模拟量表(VAS)进行测量。次要结局指标包括额外镇痛的需求、产程、分娩方式、患者满意度以及母婴不良反应。为检测两组间VAS评分1厘米(±2.6)的差异,共需214名参与者,以在α为0.05时达到80%的检验效能。
2016年8月至2019年5月,共纳入214名参与者。随机分组后排除14名。在分析的200名参与者中,102名接受氧化亚氮,98名接受静脉注射哌替啶。两组的人口统计学和产科变量具有可比性。镇痛给药后20 - 30分钟,两组的VAS评分无差异(氧化亚氮组和哌替啶组分别为7.7±2.3厘米和7.6±2.7厘米,P = 0.89)。两组在额外镇痛使用率、产程、分娩方式、阿氏评分、母乳喂养率、患者满意度或母婴不良反应发生率方面无显著差异。
经产妇在注射哌替啶和吸入氧化亚氮后20 - 30分钟的疼痛强度相当。不良反应也相当。
ClinicalTrials.gov,NCT02783508。