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评估静脉注射对乙酰氨基酚在卵母细胞采集围手术期疼痛控制中的疗效:一项随机、双盲、安慰剂对照试验。

Assessing efficacy of intravenous acetaminophen for perioperative pain control for oocyte retrieval: a randomized, double-blind, placebo-controlled trial.

机构信息

Massachusetts General Hospital Fertility Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Division of Endocrinology and Infertility, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.

Massachusetts General Hospital Fertility Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Division of Endocrinology and Infertility, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts; Department of OB/GYN, Brigham and Women's Hospital and Massachusetts General Hospital, Boston, Massachusetts.

出版信息

Fertil Steril. 2022 Jan;117(1):133-141. doi: 10.1016/j.fertnstert.2021.08.046. Epub 2021 Sep 20.

Abstract

OBJECTIVE

To compare the effect of preoperative intravenous (IV) acetaminophen versus oral (PO) acetaminophen or placebo on postoperative pain scores and the time to discharge in women undergoing oocyte retrieval.

DESIGN

Randomized, double-blind, placebo-controlled trial.

SETTING

Single academic fertility center.

PATIENT(S): Women aged 18-43 years undergoing oocyte retrieval.

INTERVENTION(S): Randomization to preoperative 1,000 mg IV acetaminophen and PO placebo (group A), IV placebo and 1,000 mg PO acetaminophen (group B), or IV and PO placebo (group C) MAIN OUTCOME MEASURE(S): Difference in patient-reported postoperative visual analog scale pain scores from baseline and the time to discharge.

RESULT(S): Of the 159 women who completed the study, there were no differences in the mean postoperative pain score differences or the time to discharge. Although not statistically significant, the mean postoperative opioid dose requirement in group A was lower than that in groups B and C (0.24 vs. 0.59 vs. 0.58 mg IV morphine equivalents, respectively) due to fewer women in group A requiring rescue pain medication (8% vs. 19% vs. 15%, respectively). Group A also reported less constipation when compared with groups B and C (19% vs. 33% vs. 40%, respectively). The rates of postoperative nausea were similar, and there were no differences in embryology or early pregnancy outcomes between the study groups.

CONCLUSION(S): Preoperative IV acetaminophen for women undergoing oocyte retrieval did not reduce postoperative pain scores or shorten the time to discharge when compared with PO acetaminophen or placebo and, thus, cannot currently be recommended routinely in this patient population.

CLINICAL TRIAL REGISTRATION NUMBER

NCT03073980.

摘要

目的

比较术前静脉(IV)给予对乙酰氨基酚与口服(PO)给予对乙酰氨基酚或安慰剂对行取卵术的女性术后疼痛评分和出院时间的影响。

设计

随机、双盲、安慰剂对照试验。

地点

单家学术生育中心。

患者

年龄 18-43 岁行取卵术的女性。

干预

随机分为术前给予 1000mg IV 对乙酰氨基酚和 PO 安慰剂(A 组)、IV 安慰剂和 1000mg PO 对乙酰氨基酚(B 组)或 IV 和 PO 安慰剂(C 组)。

主要结局测量指标

从基线到术后视觉模拟评分法疼痛评分的差异以及出院时间。

结果

在完成研究的 159 名女性中,术后疼痛评分差异或出院时间无差异。尽管无统计学意义,但由于 A 组需要解救性疼痛药物的女性较少(8%比 B 组和 C 组的 19%和 15%),A 组的平均术后阿片类药物剂量需求也低于 B 组和 C 组(分别为 0.24 比 0.59 和 0.58mg IV 吗啡当量)。与 B 组和 C 组相比(分别为 19%、33%和 40%),A 组报告的便秘也较少。术后恶心的发生率相似,各组间的胚胎学或早期妊娠结局无差异。

结论

与 PO 给予对乙酰氨基酚或安慰剂相比,行取卵术的女性术前 IV 给予对乙酰氨基酚不能降低术后疼痛评分或缩短出院时间,因此目前不能常规推荐用于该患者人群。

临床试验注册号

NCT03073980。

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