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REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia. | LitMetric

AI Article Synopsis

  • The text discusses the management of acute pain and the introduction of a fixed-dose combination drug (tramadol and dexketoprofen, TRAM/DKP) that’s commonly used in Asia for moderate to severe pain treatment since 2018.
  • A phase-IV observational study called REKOVER is being conducted in 13 hospitals across four Asian countries to evaluate the effectiveness, safety, and usage patterns of TRAM/DKP in around 750 patients, both post-surgical and non-surgical.
  • The study, ethically approved across all sites, will assess pain severity and treatment satisfaction while recording any adverse events, with plans to share the findings through conferences globally.

Article Abstract

Introduction: 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 And Analysis: 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.

Ethics And Dissemination: 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10952884PMC
http://dx.doi.org/10.1136/bmjopen-2023-080620DOI Listing

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