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对乙酰氨基酚与布洛芬用于产后早期疼痛控制的比较:一项随机对照试验。

Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial.

作者信息

Ram Shai, Madar Dotan, Ram Hila Shalev, Peleg Goni, Lior Yotam, Greenfeld Ayelet, Yakov Gala, Yogev Yariv, Maslovitz Sharon

机构信息

Lis Maternity and Women's Hospital, 6 Weitzman St, 6423906, Tel Aviv, Israel.

Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.

出版信息

Arch Gynecol Obstet. 2025 Jul;312(1):51-57. doi: 10.1007/s00404-024-07797-4. Epub 2024 Nov 5.

Abstract

INTRODUCTION

To evaluate the effectiveness of paracetamol and ibuprofen as non-opioid treatments for postpartum pain control after vaginal delivery.

MATERIALS AND METHODS

This randomized controlled study at a university-affiliated medical center involved parturient who received blindly oral tablets of either 1000 mg of paracetamol or 400 mg of ibuprofen, post-vaginal birth. Pain levels were assessed using a numeric rating scale (NRS) at four time points: before treatment, and 1, 4, and 6 h post-treatment (T0, T1, T4, and T6, respectively). We also compared the need for additional analgesia, breastfeeding initiation, mobilization, and urination following the delivery between the groups. To ensure statistical power, the study was designed to detect differences of one point on the NRS with at least 37 women per group.

RESULTS

A total of 107 women participated, including paracetamol (n = 52) and ibuprofen (n = 55) groups. Demographics and perinatal outcomes were similar across groups. No significant differences were found in the interval between delivery and request for pain control (8 ± 6-10.5 and 11 ± 6-16 h for the paracetamol and the ibuprofen, respectively, P = .13). Pain levels on the NRS were similar for both groups at all intervals. There were also no group differences in the time to the initiation of breastfeeding, mobilization, urination, or the need for additional analgesia.

CONCLUSION

Both, paracetamol and ibuprofen, can be considered equivalent and effective non-opioid alternatives for postpartum pain control. REGISTRY AT CLINICALTRIALS.GOV: (NCT04653506), https://register.

CLINICALTRIALS

gov/prs/beta/studies/S000AFOR00000066/recordSummary .

摘要

引言

评估对乙酰氨基酚和布洛芬作为非阿片类药物用于控制阴道分娩后产后疼痛的有效性。

材料与方法

这项在大学附属医院进行的随机对照研究纳入了产后接受1000毫克对乙酰氨基酚或400毫克布洛芬口服片剂盲法给药的产妇。在四个时间点使用数字评分量表(NRS)评估疼痛程度:治疗前、治疗后1小时、4小时和6小时(分别为T0、T1、T4和T6)。我们还比较了两组之间分娩后额外镇痛的需求、开始母乳喂养的情况、活动能力和排尿情况。为确保统计效能,该研究设计为每组至少37名女性,以检测NRS上一分的差异。

结果

共有107名女性参与研究,包括对乙酰氨基酚组(n = 52)和布洛芬组(n = 55)。两组的人口统计学和围产期结局相似。在分娩至要求控制疼痛的间隔时间上未发现显著差异(对乙酰氨基酚组和布洛芬组分别为8±6 - 10.5小时和11±6 - 16小时,P = 0.13)。两组在所有时间间隔的NRS疼痛水平相似。在开始母乳喂养、活动、排尿的时间或额外镇痛的需求方面两组也无差异。

结论

对乙酰氨基酚和布洛芬均可被视为等效且有效的非阿片类产后疼痛控制替代药物。临床试验注册:(NCT04653506),https://register.

临床试验

gov/prs/beta/studies/S000AFOR00000066/recordSummary 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1066/12176906/550468bbf87d/404_2024_7797_Fig1_HTML.jpg

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