Comparison of the efficacy and safety of intravenously administered dexketoprofen trometamol and ketoprofen in the management of pain after orthopaedic surgery: A multicentre, double-blind, randomised, parallel-group clinical trial.

OBJECTIVE: This study aimed to evaluate the analgesic efficacy and tolerability of dexketoprofen trometamol, a nonsteroidal anti-inflammatory drug, in comparison with that of racemic ketoprofen (both administered by intravenous infusion), in patients with postoperative pain.

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 50 mg or ketoprofen 100 mg, both administered by intravenous infusion every 8 hours over 2 days. A level of > or =40 mm on a 100 mm 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(0-8 h)) 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(0-8 h) scores in the per-protocol population were 310.9 +/- 19.2 and 326.3 +/- 19.0 mm x 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 x 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.

CONCLUSION: The two medications were equivalent in terms of analgesic activity in the management of postoperative pain after orthopaedic surgery. The high use of rescue analgesics indicates a need for a multimodal approach to analgesia in this type of surgery. Dexketoprofen trometamol appeared to show a trend towards a better tolerability profile compared with the racemic compound.