Efficacy of naproxen with or without esomeprazole for pain and inflammation in patients after bilateral third molar extractions: A double blinded crossover study

Abstract

Background: Using a double-blinded randomized crossover design, this study aimed to evaluate acute postoperative pain management, swelling and trismus in 46 volunteers undergoing extractions of the two lower third molars, in similar positions, at two different appointments who consumed a tablet of either NE (naproxen 500 mg + esomepraz ole 20 mg) or only naproxen (500 mg) every 12 hours for 4 days.

Material and methods: Parameters were analyzed: self-reported pain intensity using a visual analog scale (VAS) pre- and postoperative mouth opening; incidence, type and severity of adverse reactions; total quantity consumed of rescue medication; and pre- and postoperative swelling.

Results: Female volunteers reported significantly more postoperative pain at 1, 1.5, 2, 3 and 4hrs after surgery while also taking their first rescue medication at a time significantly earlier when consuming NE when compared to naproxen (3.7hrs and 6.7hrs). Conversely, no differences were found between each drug group in males.

Conclusions: In conclusion, throughout the entire study, pain was mild after using either drug in both men and women with pain scores on average well below 40mm (VAS), although in women naproxen improved acute postoperative pain management when compared to NE.

Figure 1

CONSORT flow diagram of the study design.

Figure 2

Postoperative Pain Scores with Naproxen (500 mg) or Naproxen with Esomeprazole (NE, 500/20 mg) in Volunteers. Visual analog scale (VAS) of self-reported postoperative pain scores after lower third molar surgeries assessed at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 48, 72 and 96 h. Scores could range from 0 to 100 mm with larger scores indicating increased pain. Data are presented as median and IQR (n = 46). * indicates a significant difference from naproxen, Mann-Whitney U test, p-value ≤ 0.05. t indicates a significant difference from women in the same group, Mann-Whitney U test, p-value ≤ 0.05.

Figure 3

Global Evaluation of Overall Experience. Self-reported global efficacy of oral naproxen (500 mg) compared to naproxen with esomeprazole (NE, 500/20 mg). during the seventh postoperative day as assessed using a 5-level Likert scale (n = 46). The format of the Likert ratings was “excellent,” “very good,” “good,” “fair,” or “poor”. * Indicates a p-value ≤ 0.05, Mann-Whitney U test for the “excellent” sub-group between research medications.