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Clinical Trial
. 2024 Oct 17;14(10):e090926.
doi: 10.1136/bmjopen-2024-090926.

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Kok Yuen Ho  1 , Bibek Gyanwali  2 , Cesar Dimayuga  3 , Edgar Michael Eufemio  4 , Edwin Bernardo  5 , Gopinathan Raju  6 , Keen Wai Chong  7 , Kritsadakorn Waithayayothin  8 , Leonardo Ona  9 , Marc Anthony L Castro  10 , Passakorn Sawaddiruk  11 , Roehl C Salvador  12 , Sharifah Ahmad Roohi  13 , Suwimon Tangwiwat  14 , Vajara Wilairatana  15 , Zhi Hao Oon  16 , Ankur Gupta  2 , Dinesh Nagrale  2
Affiliations
Clinical Trial

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Kok Yuen Ho et al. BMJ Open. .

Abstract

Objectives: This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.

Design: Real-world, prospective, multicentre, observational, phase IV study.

Setting: 13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.

Participants: Adult patients aged 18-80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.

Main outcome measures: Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).

Results: Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.

Conclusion: This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

Keywords: anaesthetics; back pain; medicine; pain management.

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Conflict of interest statement

Competing interests: BG, AG and DN are employees of A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore. All other authors report receiving investigator fees for this study from the sponsor.

Figures

Figure 1
Figure 1. Mean Numeric Pain Rating Scale (NPRS) score over time (N=599). *p<0.05 compared with predose (baseline) for all treatment groups; values represent mean NRS score.
Figure 2
Figure 2. Patient satisfaction with TRAM/DKP FDC based on Patient Global Evaluation scores. TRAM/DKP FDC, dexketoprofen trometamol 25 mg fixed-dose combination.
See this image and copyright information in PMC

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