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剖宫产术后经皮酮洛芬与芬太尼贴剂用于疼痛管理的比较、随机、双盲研究

Transdermal Ketoprofen Versus Fentanyl Patches for Pain Management Post-cesarean Section: A Comparative, Randomized, Double-Blind Study.

作者信息

Baheti Sandip, Muruganantham Sharan

机构信息

Department of Anaesthesiology, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth (Deemed to be University), Pune, IND.

出版信息

Cureus. 2024 Nov 13;16(11):e73635. doi: 10.7759/cureus.73635. eCollection 2024 Nov.

Abstract

INTRODUCTION

Postoperative pain management after a cesarean section is essential to promote mother-infant bonding and ease of breastfeeding. Transdermal patches present a viable alternative to oral medications, offering controlled drug delivery and better bioavailability while avoiding first-pass metabolism, all of which can facilitate smoother recovery and rehabilitation.

METHODS

This comparative, randomized, double-blind study was conducted on 70 parturients scheduled for cesarean section under spinal anesthesia, classified as ASA II. Patients were randomly divided into two groups: Group K (transdermal ketoprofen patch, 30 mg) and Group F (transdermal fentanyl patch, 25 mcg). The patches were applied immediately after spinal anesthesia. Pain was assessed using the Visual Analogue Scale (VAS), and sedation was assessed using the Richmond Agitation-Sedation Scale for 24 hours.

RESULTS

There was no statistically significant difference in the VAS scores between the two groups from two to 14 hours postoperatively. However, a statistically significant difference was observed at 16 hours (Group K 2 ± 0.87 vs. Group F 2.5 ± 0.86, p = 0.029) and 20 hours (Group K 1.77 ± 0.86 vs. Group F 2.33 ± 0.8, p = 0.011). Rescue analgesia was required in seven (20%) of the patients in Group K and 12 (34.29%) of the patients in Group F, though this difference was not statistically significant. At 20 hours, Group K had more alert and calm patients (33 (94.29%) vs. 26 (74.29%)), with fewer drowsy or restless patients compared to Group F (p = 0.044). At 24 hours, Group K had significantly fewer drowsy patients (0 (0%) vs. 13 (37.14%)) and more alert patients (34 (97.14%) vs. 19 (54.29%)), with fewer restless patients (p < 0.0001).

CONCLUSION

Both the ketoprofen patch (30 mg) and the fentanyl patch (25 mcg) provided comparable analgesia for the first 12 hours. However, at 16 and 20 hours, the ketoprofen patch was more effective than the fentanyl patch in providing analgesia. More patients in the fentanyl group were drowsy after 16 hours, though normal sleep patterns may have contributed to this observation.

摘要

引言

剖宫产术后的疼痛管理对于促进母婴亲密关系和便于母乳喂养至关重要。透皮贴剂是口服药物的一种可行替代方案,它能实现药物的控释,提高生物利用度,同时避免首过代谢,所有这些都有助于更顺利的恢复和康复。

方法

本比较性、随机、双盲研究针对70例计划在腰麻下行剖宫产术的产妇进行,这些产妇被分类为ASA II级。患者被随机分为两组:K组(30毫克酮洛芬透皮贴剂)和F组(25微克芬太尼透皮贴剂)。在腰麻后立即贴上贴剂。使用视觉模拟评分法(VAS)评估疼痛,并使用里士满躁动镇静量表评估24小时内的镇静情况。

结果

术后2至14小时,两组的VAS评分无统计学显著差异。然而,在16小时(K组2±0.87 vs. F组2.5±0.86,p = 0.029)和20小时(K组1.77±0.86 vs. F组2.33±0.8,p = 0.011)观察到统计学显著差异。K组有7例(20%)患者需要补救镇痛,F组有12例(34.29%)患者需要补救镇痛,尽管这一差异无统计学意义。在20小时时,K组有更多警觉且平静的患者(33例(94.29%) vs. 26例(74.29%)),与F组相比,嗜睡或烦躁不安的患者更少(p = 0.044)。在24小时时,K组嗜睡的患者显著更少(0例(0%) vs. 13例(37.14%)),警觉的患者更多(34例(97.14%) vs. 19例(54.29%)),烦躁不安的患者更少(p < 0.0001)。

结论

酮洛芬贴剂(30毫克)和芬太尼贴剂(25微克)在最初12小时提供了相当的镇痛效果。然而,在16和20小时时,酮洛芬贴剂在提供镇痛方面比芬太尼贴剂更有效。芬太尼组在16小时后有更多患者嗜睡,尽管正常的睡眠模式可能导致了这一观察结果。

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