What Is the Effect of Pre-Emptive Oral Montelukast on Postoperative Pain Following Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial

Abstract

Purpose: The aim of this study was to assess the effect of preoperative administration of oral montelukast on the amount of postoperative pain following bimaxillary orthognathic surgery.

Methods and materials: All healthy skeletal class III deformity candidates for bimaxillary orthognathic surgery were included in this triple-blind randomized clinical trial. The subjects were randomly divided into placebo and montelukast groups. One hour before the surgery, a 10 mL of apple juice was given to each and every patient; however, a 10 mg tablet of montelukast was dissolved in the juice for the intervention group. All operations were performed by the same surgical team, under the same general anesthesia protocols. The outcome variable was the amount of postoperative pain (1-, 3-, 6-, 12-, 18-, and 24-hour intervals) which was measured during the first 24 hours using a Visual Analog Scale. For statistical analysis, the significance level was set at 0.05 using SPSS 23.

Results: A total of 60 consecutive patients, comprising 31 females (51.7%) and 29 males (48.3%) with an average age of 25.2 ± 2.2 were recruited. The average surgical duration was 193 ± 28.0 minutes. In general, pain intensity exhibited an increasing trend from the first hour postoperatively, reaching its peak in the 12th hour and decreasing thereafter. Nevertheless, the average amount of pain was significantly higher in the placebo group compared with the montelukast group, in all the studied time intervals (P < .05). The number of patients who required postoperative opioid analgesics was significantly higher in the placebo group compared to the montelukast group (P = .024). Moreover, the duration of surgery had a direct and significant effect on the postoperative pain intensity (P < .001).

Conclusions: It might be concluded that preoperative administration of montelukast is effective in reducing postoperative pain following bimaxillary orthognathic surgery. Further studies are necessary for more relevancy.