PDF(Pubmed)
Abstract：
BACKGROUND: Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.
METHODS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
BACKGROUND: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
METHODS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
BACKGROUND: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
摘要：
背景：尽管存在多种治疗选择，包括固定剂量组合（FDC）药物，但对急性疼痛的满意管理仍然是一个主要的医学挑战。曲马多和右酮洛芬氨丁三醇（TRAM/DKP）75/25mgFDC于2018年在亚洲推出，广泛用于治疗中度至重度急性疼痛。关于其在亚洲患者中的有效性和安全性的数据有限，因此,需要更好地了解其在临床实践中的使用模式。我们的目标是了解TRAM/DKPFDC的使用模式，其在亚洲中度至重度急性疼痛患者中的有效性和耐受性。
方法：REKOVER是第四阶段，多国,多中心,prospective,真实世界的观察研究。共有750名术后和非手术患者（男性和女性，18-80岁)将从新加坡的13家三级医院(15家医院)招募，泰国,菲律宾和马来西亚。所有接受TRAM/DKPFDC处方并愿意参与研究的患者将被招募。每个网站的招聘时间为6个月。在第1天至第5天的治疗期间，将使用数字疼痛评定量表收集疼痛的严重程度，同时在治疗结束时使用患者总体评估量表评估对治疗的满意度。在研究期间报告的任何不良事件将被记录用于安全性分析(直到第6天)。研究数据将输入ClaimIt门户和移动应用程序(app)(ObvioHealth,美国）。所有的住院病人数据将被输入到门户网站的研究网站和门诊病人将通过应用程序完成。
背景：该研究已获得新加坡各研究中心当地伦理委员会的批准，泰国,菲律宾和马来西亚。调查结果将通过地方和全球会议介绍传播，同行评审科学期刊和继续医学教育的出版物。
方法：REKOVER是第四阶段，多国,多中心,prospective,真实世界的观察研究。共有750名术后和非手术患者（男性和女性，18-80岁)将从新加坡的13家三级医院(15家医院)招募，泰国,菲律宾和马来西亚。所有接受TRAM/DKPFDC处方并愿意参与研究的患者将被招募。每个网站的招聘时间为6个月。在第1天至第5天的治疗期间，将使用数字疼痛评定量表收集疼痛的严重程度，同时在治疗结束时使用患者总体评估量表评估对治疗的满意度。在研究期间报告的任何不良事件将被记录用于安全性分析(直到第6天)。研究数据将输入ClaimIt门户和移动应用程序(app)(ObvioHealth,美国）。所有的住院病人数据将被输入到门户网站的研究网站和门诊病人将通过应用程序完成。
背景：该研究已获得新加坡各研究中心当地伦理委员会的批准，泰国,菲律宾和马来西亚。调查结果将通过地方和全球会议介绍传播，同行评审科学期刊和继续医学教育的出版物。
