A Randomized Double-Blind Comparative Study of Efficacy and Safety Between Low-Dose Etoricoxib and Ibuprofen Coadministered with Low-Dose Paracetamol for Dental Pain

Abstract

Objective: To study the safety and efficacy of low-dose etoricoxib and low-dose paracetamol versus ibuprofen and low-dose paracetamol treatments in patients who experienced acute pain after tooth extraction. Methods: A total of 80 patients were recruited and randomized to two study groups, i.e., EP and IP. Group EP received etoricoxib 30 mg once a day and add-on paracetamol 325 mg eight-hourly, and Group IP received ibuprofen 400 mg and paracetamol 325 mg eight-hourly for three days. The analgesic efficacy was assessed by a visual analog scale, pain relief score, and global evaluation score. Patients were assessed at 0, 6, 24, 48, and 72 h. Safety was assessed by the patient's estimation of the severity of adverse drug reactions using a 3-point scale and the type of adverse drug reactions reported by the patients after 72 h. Results: Mean pain intensity reduction, mean pain relief score, and global evaluation score all showed better analgesic efficacy results in Group EP as compared to Group IP but were not significant (P >0.05) at 6, 24, 48, and 72 h, respectively. No patient had reported any serious adverse drug reaction in both the groups. Mild to moderate adverse reactions were reported in 20% cases in the IP group and 10% cases in the EP group; however, the incidence of GIT intolerance was seen in 17.5% of the cases in the IP group and none in the EP group. Conclusion: Low-dose etoricoxib with low-dose paracetamol has comparable analgesic efficacy with better safety than therapeutic dose ibuprofen and low-dose paracetamol.