A comparison of nimesulide beta cyclodextrin and nimesulide in postoperative dental pain

The aim of this study was to assess the efficacy and tolerability of single doses of nimesulide beta cyclodextrin compared with nimesulide in patients with dental pain following surgical procedures. This was a randomised, dou ble-blind, between-patient, multicentre study involving 148 outpatients suf fering from moderate to severe pain, who received single doses of either 40 0 mg nimesulide beta cyclodextrin or 100 mg nimesulide. The principal crite rion for efficacy was pain intensity assessed on a visual analogue scale (V AS) 15 minutes after drug intake. Pain intensity was further evaluated 30, 45, 90, 120, 180, 240 and 360 minutes after dosing. Pain relief was evaluat ed at the same time points by means of a categorical scale. The time point of first pain relief, the use of rescue medication and the global evaluatio n of efficacy were also recorded. The reduction in pain intensity was signi ficantly more pronounced in the nimesulide beta cyclodextrin group at 15, 3 0, 45 and 60 minutes (p<0.01). Pain relief was significantly greater (p<0.0 5) and more rapid with nimesulide beta cyclodextrin. In the patient overall assessment of efficacy, nimesulide beta cyclodextrin and nimesulide were r ated excellent or good by 95% and 92% respectively; only one patient in the nimesulide beta cyclodextrin group needed rescue medication. Both study dr ugs were effective and well tolerated in the treatment of acute dental pain , with nimesulide beta cyclodextrin showing a faster onset of analgesic act ion.