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酮洛芬和双氯芬酸透皮贴剂与口服双氯芬酸片剂治疗牙髓术后疼痛疗效的比较评价——一项随机临床试验

Comparative Evaluation of Efficacy of Ketoprofen and Diclofenac Transdermal Patches with Oral Diclofenac Tablet on Postoperative Endodontic Pain- A Randomized Clinical Trial.

作者信息

Porwal Priya, Shah Nimisha, Singh Rao Ajay, Jain Ihit, Maniangat Luke Alexander, Shetty Krishna Prasad, Reda Rodolfo, Testarelli Luca, Pawar Ajinkya M

机构信息

Department of Conservative Dentistry and Endodontics, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Vadodara, Gujarat, India.

Department of Dental Sciences, GBH American Hospital, Udaipur, Rajasthan, India.

出版信息

Patient Prefer Adherence. 2023 Sep 27;17:2385-2393. doi: 10.2147/PPA.S421371. eCollection 2023.

Abstract

PURPOSE

Evaluate the efficacy of transdermal patches containing ketoprofen and diclofenac sodium compared to oral diclofenac tablets in reducing post-endodontic pain after single-visit root canal therapy for teeth with symptomatic irreversible pulpitis.

METHODS

A total of 78 eligible participants with symptomatic irreversible pulpitis and preoperative VAS scores of 4 or above were enrolled after obtaining ethical approval (SVIEC/ON/DENT/SRP/22064) and CTRI registration (CTRI/2022/07/044231). Exclusion criteria included pregnancy, lactation, fractured/cracked teeth, developmental anomalies, tooth pathology, or ongoing analgesic/NSAID use. After root canal treatment, participants were randomized into three groups using computer randomization. Groups A and B received transdermal patches with Ketoprofen and diclofenac sodium, respectively, applied to the right forearm for 24 hours, with an additional patch on the left forearm for the next day. Group C received four diclofenac sodium oral tablets, twice daily for two days. VAS scales were used to assess pain at 4, 8, 24, and 48 hours post-treatment. The VAS scores collected were tabulated and statistically analyzed using SPSS version 21 with (P < 0.05). Shapiro Wilk test and the Related Samples Friedman's Two-Way Analysis of Variance by Ranks were used for statistical evaluation.

RESULTS

Statistically significant reductions in mean postoperative pain scores were observed across all groups at all time points compared to preoperative scores. Notably, the Ketoprofen patch group exhibited superior performance compared to the diclofenac transdermal patch and oral diclofenac tablet groups at 48 hours, with statistical significance (p=0.047).

CONCLUSION

The present evidence substantiates the efficacy of transdermal patches containing diclofenac and ketoprofen in managing postoperative pain arising from symptomatic irreversible pulpitis in single-rooted teeth. By avoiding the use of oral NSAIDs, these patches provide effective pain relief while minimizing the risk of adverse effects, presenting a favorable option for patients.

摘要

目的

评估含酮洛芬和双氯芬酸钠的透皮贴剂与口服双氯芬酸片相比,在单颗有症状不可逆性牙髓炎牙齿的一次性根管治疗后减轻根管治疗后疼痛的疗效。

方法

在获得伦理批准(SVIEC/ON/DENT/SRP/22064)和CTRI注册(CTRI/2022/07/044231)后,共纳入78名符合条件的有症状不可逆性牙髓炎且术前视觉模拟评分(VAS)为4分及以上的参与者。排除标准包括妊娠、哺乳期、牙齿折断/裂开、发育异常、牙齿病变或正在使用镇痛药/非甾体抗炎药。根管治疗后,使用计算机随机分组将参与者随机分为三组。A组和B组分别接受含酮洛芬和双氯芬酸钠的透皮贴剂,贴于右前臂24小时,次日在左前臂再贴一片。C组接受四片双氯芬酸钠口服片剂,每天两次,共两天。在治疗后4、8、24和48小时使用VAS量表评估疼痛。收集的VAS评分制成表格,并使用SPSS 21版进行统计学分析(P<0.05)。采用Shapiro Wilk检验和相关样本Friedman双向秩方差分析进行统计学评估。

结果

与术前评分相比,所有组在所有时间点的术后平均疼痛评分均有统计学意义的降低。值得注意的是,酮洛芬贴剂组在48小时时表现优于双氯芬酸透皮贴剂组和口服双氯芬酸片剂组,具有统计学意义(p = 0.047)。

结论

现有证据证实含双氯芬酸和酮洛芬的透皮贴剂在管理单根牙有症状不可逆性牙髓炎术后疼痛方面的疗效。通过避免使用口服非甾体抗炎药,这些贴剂在减轻不良反应风险的同时提供有效的疼痛缓解,为患者提供了一个有利的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4378/10544139/c3974492edf2/PPA-17-2385-g0001.jpg

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