A Preliminary Study on the Effective Dose and Safety of Zomepirac Sodium

Pain following minor surgery and tooth extraction in the field of dentistry

Abstract

The effective dose and safety of zomepirac were evaluated in a double-blind controlled study, using mefenamic acid as a control drug, in the treatment of pain after minor surgical procedures of after tooth extraction in the field of dentistry.
One hundred and nine patients were included in the statistical analyses. The results obtained were as follows.
1) No difference was found in any patient demographic parameter among the drug treatment groups included in evaluation of drug efficacy.
2) In respect to the analgesic efficacy after the first dose, the zomepirac sodium a 100mg group (here-after referred to as Z 100 group) was significantly superior to the zomepirac sodium 50mg group (hereafter referred to as Z 50 group), and the mefenamic acid group (hereafer referred to as M group) tended to be superior to the Z 50 group.
3) The Z 100 group tended to be superior to the M group at 30 minutes after treatment in pain intensity and pain intensity difference.
4) The time of onset of analgesic action did not differ significantly among the drug treatment groups. However, the duration of action tended to be longer in the Z 100 group than in the Z 50 group.
5) Patient's impression tended to be rated better in the Z 100 group than in the Z 50 group. However, evaluation by the doctor in charge showed no significant difference among the drug treatment groups.
6) No significant difference was found in the incidence of side effects, safety evaluation or utility evaluation among the drug treatment groups.
From the above, it was indicated that in analgesic efficacy, zomepirac 100mg was significantly superior to zomepirac 50mg and equal to or superior to mefenamic acid and that in safety, the three drug groups are almost equal.