Double-blind placebo-controlled comparison of the analgesic effects of single doses of lornoxicam and aspirin in patients with postoperative dental pain. A randomized, double-blind, placebo-controlled, dose-response study of the analgesic effect of lornoxicam after surgical removal of mandibular third molars. Analgesic efficacy of quick-release versus standard lornoxicam for pain after third molar surgery: a randomized, double-blind, placebo-controlled, single-dose trial.
The pain experienced after third molar surgery was used as a model to evaluate the analgesic efficacy of a new non-steroidal anti-inflammatory drug, lornoxicam, in a Phase II study. One hundred and fifty fit, young adults participated in this randomised, single dose, double-blind, parallel group clinical study. Three doses of lornoxicam (2 mg, 4 mg, and 8 mg) were compared with aspirin 650 mg and placebo. Patients suffering from moderate to severe pain following surgery were monitored for up to 8 hours. All indices of efficacy showed similar results, all active treatments being associated with highly significant (P less than 0.0001) reductions in pain during the study period. Lornoxicam 8 mg demonstrated significant analgesic efficacy as compared with placebo. The two lower doses of lornoxicam and aspirin all showed apparent degrees of efficacy intermediate between that of placebo and lornoxicam 8 mg, although the trial proved to have inadequate power to show significant differences between these three treatments. Lornoxicam was very well tolerated at all three doses studied, with no adverse events definitely attributable to its administration. The aim of the present study was to investigate the dose-effect relationship of single doses of 4 to 32 mg of lornoxicam (LNX), a new nonsteroidal antiinflammatory drug belonging to the oxicam group, compared with placebo and 10 mg ketorolac (KET) in the treatment of pain after oral surgery. Also, it was the aim of the study to evaluate the relationship between adverse events and different doses of LNX. After the surgical removal of a mandibular third molar, test medication was taken when the patients experienced at least moderate pain. After medication, pain relief, pain intensity, and any discomfort from the medication were noted in a questionnaire. Paracetamol was used as rescue medication. A total of 278 patients completed the study according to the protocol. The primary efficacy parameter was total pain relief after 6 hours, and all active treatments showed significantly better effect than placebo, with LNX 16 and 32 mg being significantly superior to LNX 4 mg. All other efficacy parameters showed the same dose-effect relationship. A total of 37 adverse events were reported evenly distributed in the 6 treatment groups; only 3 of these were considered severe, and all disappeared without treatment. In conclusion, the study showed a dose-effect relationship of LNX without a rise in adverse events. The effect of 10 mg KET seemed to be at the level of 8 to 16 mg LNX. The aim of this study was to evaluate the analgesic efficacy and time to onset of effect of the lornoxicam quick-release (LNX-QR) tablet compared with the standard-release tablet (LNX-ST).
                In this randomized, double-blind, single-dose trial, 200 patients with moderate pain after surgical removal of an impacted third molar were randomized to treatment with an LNX-QR 8 mg tablet (80 patients), an LNX-ST 8 mg tablet (80 patients) or placebo (40 patients). Pain intensity (PI) and pain relief (PAR) were assessed (numerical and verbal rating scales) for 6 hours, and time to onset of PAR was recorded. The cumulated sum of PI differences (SPID) and PAR (TOTPAR) were calculated. Tolerability was evaluated by occurrence of adverse events.
                Kaplan-Meier analysis of time to onset of analgesic efficacy demonstrated a significantly faster onset with LNX-QR than placebo or LNX-ST (p < 0.0001). Median time of onset was 32 minutes (range 29-37) for LNX-QR and 46 minutes (range 37-59) for LNX-ST. The analgesic efficacy of LNX-QR and LNX-ST were superior to that of placebo, whereas paired comparisons of TOTPAR and SPID showed LNX-QR to be superior to LNX-ST (p < 0.05).
                LNX-QR provided a faster onset and superior analgesic effect against pain following third molar surgery than LNX-ST.
Oral lornoxicam is effective at treating moderate to severe acute postoperative pain, based on limited data. Adverse events did not differ significantly from placebo.