Tramadol hydrochloride 75 mg/dexketoprofen 25 mg oral fixed-dose combination in moderate-to-severe acute pain: Sustained analgesic effect over a 56-h period in the postoperative setting

Abstract

Multimodal analgesia constitutes a common strategy in pain management. A tramadol hydrochloride 75 mg/dexketoprofen 25 mg oral fixed combination (TRAM/DKP 75 mg/25 mg) has been recently registered and released in Europe for the treatment of moderate-to-severe acute pain. This paper provides additional analyses on the results of two phase III clinical trials (DEX-TRA-04 and DEX-TRA-05) on postoperative pain to document its sustained effect. The analysis was applied to a modified intention-to-treat population (mITT, n = 933) of patients undergoing active treatment from the first dose, to assess the sustained effect of TRAM/DKP 75 mg/25 mg on pain intensity (PI-VAS 0-100) over 56 h from first drug intake. The superior analgesic effect of TRAM/DKP 75 mg/25 mg over 56 h in terms of difference in PI-VAS (mean [SE]) was shown for DEX-TRA-04 (-11.0 [0.55] over dexketoprofen 25 mg and -9.1 [0.55] over tramadol 100 mg, P ≤ 0.0001) and for DEX-TRA-05 (-10.4 [0.51] over dexketoprofen 25 mg and -8.3 [0.51] over tramadol 100 mg, P ≤ 0.0001). The statistical analysis performed on data coming from both studies confirms the superior sustained analgesia of TRAM/DKP 75 mg/25 mg over tramadol 100 mg and dexketoprofen 25 mg. These results are consistent with the previously published data obtained on the ITT population and strongly support the role of this oral fixed-dose combination in the treatment of moderate-to-severe acute pain.

Avoid Postoperative Pain To Prevent Its Chronification: A Narrative Review

“…The DEX-TRA fixed-dose combination product was evaluated in several clinical trials [38][39][40][41][42][43][44]. Efficacy and safety were confirmed for pain control following oral surgery [38,39], abdominal hysterectomy [40], and total hip arthroplasty [41].…”

Critical Appraisal of Current Acute LBP Management and the Role of a Multimodal Approach

“…The fixed dose combination tramadol/dexketoprofen (TRAM/DKP) holds great promise for the multimodal pain management. Of note, the rapid onset of analgesic effect of DKP, with its anti-inflammatory activity, associated to the sustained (mean duration: 8.1h) action of TRAM, makes this combination a valuable tool to achieve rapidly acting and long lasting multimodal analgesia [100][101][102][103][104][105]. Owing to its central analgesic effect, peripheral analgesic action, and anti-inflammatory activity [86], TRAM/DKP may contribute to pain relief in acute exacerbations of LBP [106].…”

Principles of choosing an analgesic depending on the intensity of pain

“…Мультимодальна аналгезія є ще однією стратегією лікування болю. Фіксована пероральна комбінація трамадолу гідрохлориду 75 мг/декскетопрофену 25 мг, що була зареєстрована й випущена в Європі для лікування помірного й сильного гострого болю, має стійкий знеболювальний ефект протягом 56 годин [18]. У більшості наведених досліджень та оглядів автори поряд з ефективністю декскетопрофену відзначали й безпеку його застосування [19].…”