Comparison of the Efficacy and Safety of Intravenously Administered Dexketoprofen Trometamol and Ketoprofen in the Management of Pain after Orthopaedic Surgery

Methods: This was a multicentre, randomised, double-blind, parallel-group study. 252 patients with moderate to severe pain following hip or knee replacement surgery performed under general anaesthesia were randomly assigned to receive either dexketoprofen trometamol 50mg or ketoprofen 100mg, both administered by intravenous infusion every 8 hours over 2 days. A level of ≥40mm on a 100mm visual analogue scale (VAS) for pain was required for inclusion in the study. Pain intensity on the VAS at different time-points after the administration of the first dose was assessed and the sum of pain intensity differences (SAPID_0–8h) was calculated as the primary efficacy variable. The use of rescue medication, maximum pain intensity difference (PID_max), time to PID_max and safety were also evaluated.

Results: The mean (± SE) adjusted SAPID_0–8h scores in the per-protocol population were 310.9 ± 19.2 and 326.3 ± 19.0 mm · h after dexketoprofen trometamol and ketoprofen treatment, respectively. The 95% CI for the difference between treatments (−59.1 to 28.3) was fully included within the range of equivalence of ±65.3 mm · h. There were no significant differences with regard to secondary variables. The need for rescue analgesia was high in both groups; 81.3% of patients receiving dexketoprofen trometamol treatment and 87.1% receiving ketoprofen treatment required rescue analgesia. The time to achieve PID_max was 284.7 and 308.5 min after dexketoprofen and ketoprofen, respectively. Treatment-related adverse events were experienced by 16% of patients in the dexketoprofen trometamol group compared with 21.3% in the ketoprofen group. Most patients were concomitantly treated with low-molecular-weight heparin (94.4%), and no haemorrhagic events related to the surgical procedure were reported. No adverse events related to renal function were detected during the study.