ANALGESIC EFFECTS OF PREEMPTIVE CELECOXIB OR TRAMADOL/ACETAMINOPHEN ADDED TO STANDARD POSTOPERATIVE PAIN MANAGEMENT IN IMPACTED MANDIBULAR THIRD MOLAR EXTRACTION: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Abstract

Objectives: This study aimed to assess the efficacy and safety of adding single-dose preemptive celecoxib 200 mg (Cc) or tramadol 37.5 mg/acetaminophen 325.0 mg (T/A) to standard postoperative analgesia after impacted mandibular third molar extraction, a design not previously explored.

Methods: In this multicenter, prospective, randomized, double-blind, placebo-controlled, crossover within-subject study, participants were randomly assigned to 2 groups (Cc or placebo for group A; T/A or placebo for group B) and underwent impacted mandibular third molar extraction on both sides at 1-month intervals. Along with baseline characteristics, pain intensity in Visual Analogue Scale (VAS), first perceived pain occurrence, rescue medication use, and adverse events were evaluated.

Results: A total of 33 participants per group completed the trial. Cc reduced pain at 3 (-0.91 ± 2.17; P = .011) and 6 hours (-0.85 ± 2.24; P = .018), while T/A reduced pain at 1 (-1.40 ± 2.37; P < .001), 2 (-0.79 ± 2.32; P = .030), and 6 hours (-0.91 ± 1.94; P = .006) postextraction, with some insignificant reductions at other times. Both Cc and T/A were effective in reducing the first perceived pain. Notably, Cc significantly decreased pain intensity, T/A significantly delayed the pain perception. Both drugs had no significant effect on the need for rescue medication or adverse event rates.

Conclusions: Based on these results, both Cc and T/A appears to aid in reducing postoperative pain following impacted mandibular third molar extraction without significant adverse effects.

Keywords: Celecoxib; Impacted third molar extraction; Multimodal analgesia; Preemptive analgesia; Tramadol/AAP.