Efficacy and Safety of a Fixed-Dose Combination of Etoricoxib-Tramadol Biphasic Tablet in Moderate-to-Severe Acute Pain: A Randomized, Double-Blind, Parallel-Group, Active-Controlled Trial.

Objectives

The aim of the present study was to evaluate the efficacy and safety of etoricoxib-tramadol 120 mg/100 mg (Eto-Tr) in acute moderate-to-severe pain.

Methods

Eto-Tr once a day (n = 29) or naproxen 220 mg + tramadol 50 mg (Nap-Tr) every 12 h (n = 28) were administered after a third molar extraction for three days. Pain intensity difference at 4 h (PID4) was determined as the primary outcome. In addition, total pain relief (TOTPAR), trismus control, and adverse events were addressed.

Results

The population PID4 score was 0 mm (Nap-Tr IQR 13 mm; Eto-Tr IQR 35 mm; p = 0.182). No differences for PID scores were observed (1 h to 72 h). TOTPAR increased gradually from 35.71% (Nap-Tr) and 39.39% (Eto-Tr) at 4 h to 67.86% (Nap-Tr) and 58.62% (Eto-Tr) at 72 h. Sustained pain relief over time and clinically meaningful trismus reduction was also observed (Nap-Tr: 4 mm [IQR 28.10] vs. Eto-Tr: 9.8 mm [IQR 12.3], p = 0.175). Common adverse events were notified [Nap-Tr (n = 5, 19%); Eto-Tr (n = 8, 27%)].

Conclusions

The once-daily administration of Eto-Tr 120 mg/100 mg showed similar efficacy and safety to conventional treatment in moderate-to-severe acute pain. The once-daily regimen together with a multimodal analgesia represents a suitable patient-centered alternative for pain management.