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, double-blind, between-patient, multicentre study involving 148 outpatients suffering from moderate to severe
pain, who received single doses of either 400 mg
nimesulide beta cyclodextrin or 100 mg
nimesulide. The principal criterion for efficacy was
pain intensity assessed on a visual analogue scale (VAS) 15 minutes after
drug intake.
Pain intensity was further evaluated 30, 45, 90, 120, 180, 240 and 360 minutes after dosing.
Pain relief was evaluated 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 evaluation of efficacy were also recorded. The reduction in
pain intensity was significantly more pronounced in the
nimesulide beta cyclodextrin group at 15, 30, 45 and 60 minutes (p < 0.01).
Pain relief was significantly greater (p < 0.05) and more rapid with
nimesulide beta cyclodextrin. In the patient overall assessment of efficacy,
nimesulide beta cyclodextrin and
nimesulide were rated excellent or good by 95% and 92% respectively; only one patient in the
nimesulide beta cyclodextrin group needed rescue medication. Both study drugs were effective and well tolerated in the treatment of acute dental
pain, with
nimesulide beta cyclodextrin showing a faster onset of
analgesic action.