Gaballah Kamis, Eldohaji Tuleen, Tannir Maha El, Shaban Roula, Habib Ruaa, Ali Kamran
Department of Oral and Craniofacial Sciences, College of Dental Medicine, University of Sharjah, Sharjah, United Arab Emirates.
Intern Dentists, University Dental Hospital, University of Sharjah, Sharjah, United Arab Emirates.
Sci Rep. 2025 Apr 3;15(1):11519. doi: 10.1038/s41598-025-89744-0.
The use of multimodal analgesia is a common practice in clinical settings, where a combination of drugs with different mechanisms of action is used to enhance the effectiveness of an analgesic and reduce its adverse effects. This study aimed to compare the efficacy of concurrent ibuprofen and paracetamol with alternate administration in the management of postoperative pain after the surgical removal of impacted mandibular third molars. A single-center, double-masked, parallel-group, randomized controlled clinical trial involved 56 patients undergoing scheduled surgical extraction of impacted mandibular third molars. Patients were randomly assigned to either Group A (Control), where they were instructed to take one tablet of ibuprofen 400 mg and two tablets of paracetamol 500 mg together every 8 h for 48 h, or Group B (Study), where they were instructed to take one tablet of ibuprofen 400 mg and two tablets of paracetamol 500 mg alternatively every 4 h for 48 h. The primary outcome measure was the intensity of postoperative pain, which was evaluated using a Visual Analogue Scale (VAS) ranging from 0 to 10. The secondary outcome measure was the timing of the onset of the analgesic effect, the duration of pain relief, the frequency of rescue drug administration, and the time interval between taking the recommended medication and the need for rescue medication. Investigators involved in analyzing the patients' responses were blinded to the pain control regime used by the participants. Pain intensity during the first 48 h after the extractions showed that most participants experienced "some pain," including 50% in Group A and 35.7% in Group B. The percentage of patients reporting "no pain" was higher in group B than in group A, although the difference was not statistically significant (p = 0.495). More than half of the participants (53%) in group A reported needing an extra dose in the 48-hour follow-up period, while 85% in group B reported pain relief (p = 0.002). When correlating the mean pain score to the complexity level, in patients with moderate complexity of extraction, higher pain scores were recorded in group B. The findings of this study show that the combination of Paracetamol and Ibuprofen are well-tolerated and effective option for post operative pain after surgical removal of mandibular third molars. Use of Paracetamol and Ibuprofen alternatively in the first 48 h showed a more effective pain control compared to concurrent use of these medications. However given the small sample size and patients recruited from a single center, multicenter studies with a bigger sample size and stratified complexity groups would enhance the generalizability of the findings.This trial protocol was registered with ClinicalTrials.gov (Registration No: NCT06514222 dated 23/07/2024).
多模式镇痛在临床环境中是一种常见的做法,即使用具有不同作用机制的药物组合来提高镇痛效果并减少其不良反应。本研究旨在比较布洛芬和对乙酰氨基酚同时服用与交替服用在拔除下颌阻生第三磨牙术后疼痛管理中的疗效。一项单中心、双盲、平行组、随机对照临床试验纳入了56例计划接受下颌阻生第三磨牙拔除术的患者。患者被随机分为A组(对照组),指导他们每8小时同时服用一片400毫克的布洛芬和两片500毫克的对乙酰氨基酚,共服用48小时;或B组(研究组),指导他们每4小时交替服用一片400毫克的布洛芬和两片500毫克的对乙酰氨基酚,共服用48小时。主要结局指标是术后疼痛强度,使用0至10的视觉模拟量表(VAS)进行评估。次要结局指标是镇痛效果开始的时间、疼痛缓解的持续时间、急救药物给药的频率,以及服用推荐药物与需要急救药物之间的时间间隔。参与分析患者反应的研究人员对参与者所采用的疼痛控制方案不知情。拔牙后前48小时的疼痛强度显示,大多数参与者经历了“一些疼痛”,A组为50%,B组为35.7%。报告“无疼痛”的患者百分比B组高于A组,尽管差异无统计学意义(p = 0.495)。A组超过一半的参与者(53%)报告在48小时随访期内需要额外一剂药物,而B组85%的参与者报告疼痛得到缓解(p = 0.002)。当将平均疼痛评分与拔牙复杂程度相关联时,在拔牙复杂度为中度的患者中,B组记录到更高的疼痛评分。本研究结果表明,对乙酰氨基酚和布洛芬的组合对于拔除下颌第三磨牙术后疼痛是耐受性良好且有效的选择。与同时使用这些药物相比,在最初48小时内交替使用对乙酰氨基酚和布洛芬显示出更有效的疼痛控制。然而,鉴于样本量小且患者来自单一中心,进行更大样本量和分层复杂程度组别的多中心研究将提高研究结果的可推广性。本试验方案已在ClinicalTrials.gov注册(注册号:NCT06514222,日期为2024年7月23日)。