INTRODUCTION: The aim of this prospective, randomized, double-blind clinical trial was to evaluate the effect of a preoperative, single, oral dose of diclofenac potassium (DFK) on postoperative pain and rescue analgesic intake in patients with symptomatic irreversible pulpitis in mandibular molars treated in 1 visit.
METHODS: Seventy emergency patients with moderate to severe preoperative pain randomly received either 50 mg DFK or placebo tablets 1 hour before starting endodontic treatment (n = 35 per group). Patients recorded their pain level 6, 12, 24, and 48 hours after treatment on a 170-mm Heft-Parker visual analog scale. The incidence of rescue analgesic intake was also recorded. Outcome data were statistically analyzed using Mann-Whitney U, Friedman, Wilcoxon signed rank, and chi-square tests. Binary logistic regression assessed the association of predisposing factors with postoperative pain. The significance level (α) was set at 0.05.
RESULTS: Of the 70 patients, 68 were analyzed (n = 34 per group). Both groups had similar baseline characteristics (P > .05). DFK showed significantly less pain incidence and intensity than the placebo at 48 hours only (P < .05). A significant decrease occurred from 24 to 48 hours with DFK (P < .05), which was not recorded with the placebo (P > .05). No difference in the incidence of rescue analgesic intake was reported between groups (P > .05). Food intake timing, sex, and rescue analgesic intake were associated with postoperative pain (P < .05).
CONCLUSIONS: Premedication by a single, oral dose of 50 mg DFK could be effective in reducing postendodontic pain at 48 hours after 1-visit endodontic treatment in mandibular molars with symptomatic irreversible pulpitis.