Double-blind randomized placebo-controlled clinical trial of efficacy of preoperative diclofenac sodium in the control of post-endodontic pain

Abstract

Aim: The aim of the present study was to compare the efficacy of preoperative diclofenac sodium in the control of post-endodontic pain. Materials and Method: Sixty patients were randomly selected and clinical examinations were conducted by three operators. The patients were randomly allocated using simple randomization technique into 2 experimental groups: Group 1, diclofenac sodium (VOVERON SR, 100 mg-oral) and Group 2, placebo (sucrose tablets). Both medications were administered 30 min before conventional root canal therapy. To maintain the double-blind design, a second investigator provided the two agents, and each tablet was disguised so that the patient as well as the operator was not aware of the medication. Patients were instructed to complete a pain diary; 6, 12, and 24 h after root canal instrumentation. The method used to measure clinical pain intensity was the visual analogue scale (VAS), which consisted of a 10 cm line anchored by two extremes, “no pain” and “pain as bad as it could be.” Thus, the pain intensity was assigned into four categorical scores: a) None (0); b) Mild (1-3); c) Moderate (4-6); and d) Severe (7-10). Results: Among the 60 volunteers who completed the study, 63.63% had mild pain and 36.37% had severe pain. Post endodontic pain showed a statistically significant difference between group 1 and group 2 at 6hr, 12hr and 24hr (p< 0.05). Conclusion: Post endodontic pain was substantially reduced by preoperative administration of a single oral dose of diclofenac sodium as compared to the placebo group.