Pre-emptive Montelukast and Its Effect on Clinical Outcomes After Mandibular Third Molar Surgery: A Triple-blinded Randomized Controlled Trial

Abstract

Background: Cyclooxygenase inhibitors are well-studied for pain and swelling control after mandibular third molar extraction, while the lipoxygenase pathway and leukotriene receptor antagonists, like montelukast, remain less researched.

Purpose: The purpose of the study was to measure and compare postoperative pain relief from single pre-emptive doses of montelukast and etoricoxib.

Study design: The investigators conducted a triple-blinded, placebo-controlled randomized clinical trial and enrolled a sample of patients who presented to the All India Institute of Medical Sciences, Mangalagiri, between January 2023 and April 2023 for evaluation and management of impacted lower third molars. Patients with active inflammation or infection in the third molar region were excluded from the study.

Predictor variable: The predictor variable was pre-emptive analgesic regimen: montelukast, etoricoxib, or a placebo, and subjects were randomly assigned to 3 groups.

Outcome variable(s): The primary outcome variable was the intensity of postoperative pain, measured using an 11-point visual analog scale at 0, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours, and 7 days postsurgery. Secondary outcome variables included changes in tissue tumor necrosis factor-alpha levels, the need for rescue analgesia, edema, and trismus.

Covariates: The study covariates included demographic and surgical characteristics.

Analyses: Bivariate analyses were conducted using the χ² test or one-way ANOVA, while univariate analysis utilized repeated-measures ANOVA to assess outcome changes over time, followed by post-hoc comparisons for group differences. Statistical significance was set at P < .05.

Results: Forty-eight participants were randomized into 3 equal groups of 16, with no statistically significant differences in clinicoradiographic or surgical characteristics (P > .2). At 2 hours postoperatively, the mean pain score was significantly lower in the etoricoxib group (2.19 ± 2.0) compared to the montelukast and placebo groups (3.06 ± 1.6 and 4.13 ± 1.9, respectively) (P = .01; 95% CI: -3.60 to -0.27). Repeated-measures ANOVA revealed a statistically significant interaction between time and treatment group (P = .008). Post hoc analysis showed significantly lower pain intensity at 2 hours in the etoricoxib group compared to the placebo group (P = .01; 95% CI: -3.60 to -0.27).

Conclusion: In third molar surgery, pre-emptive etoricoxib reduced postoperative pain, while montelukast decreased inflammation and modulated tumor necrosis factor-alpha levels. The results of the study do not support the use of the alternative pre-emptive analgesic regimens.