Eficácia analgésica e início de ação de diferentes formulações de ibuprofeno no controle da dor pós-operatória em cirurgias de terceiros molares: um ensaio clínico, randomizado, duplo cego, boca dividida

Abstract

The pharmaceutical formulation of a drug is an essential tool that has the purpose of facilitating its administration and obtaining the greatest desired therapeutic effect. Thus, the availability of the drug from the pharmaceutical form assumes a critical role in the clinical effectiveness of a drug. Surgery to remove third molars is a procedure often performed in dentistry, being associated with varying degrees of postoperative pain. Therefore, immediate control and an understanding of the pathophysiological mechanisms of postoperative pain and control strategies are essential in clinical practice. Knowledge of the different formulations and appropriate doses of medications are essential for immediate pain control, since most patients experience moderate to severe pain in these procedures. Ibuprofen (IBU) is a non-steroidal anti-inflammatory drug (NSAID), widely used for the treatment of postoperative pain, administered orally, in doses of 400 to 600mg, every 6-8 hours, preferably after meals. Improvements in the pharmacokinetics of ibuprofen have led to the development of new formulations and new ibuprofen salts with a faster dissolution rate. Thus, the aim of the present study was to evaluate the onset of action and effectiveness of different formulations of ibuprofen in controlling postoperative pain in patients undergoing third molar surgery. A randomized, double-blind, divided mouth, clinical trial was conducted with volunteers who needed the removal of the third mandibular molars with similar patterns of bone inclusion and surgical difficulty between the right and left sides, and required osteotomy. Eligible patients were randomly assigned to 2 groups to receive a single dose (400 mg) of ibuprofen gel capsules (Alivium), Ibuprofen drops 100mg / ml (Alivium), 4ml single dose dissolved in 100 ml of water or placebo. The parameters of onset of action and analgesic efficacy of ibuprofen were evaluated in different presentations with the visual analog scale, which was applied immediately, 15 minutes, 30 minutes, 1h, 2h, 4h and 6 hours after the surgery, where the patient reported the intensity of pain, as well as day and time. As a result, we can see in terms of the analgesic efficacy of IBU formulations, there was no statistically significant difference between the gel capsule - drops solution (p> 0.05), over time when assessing peak pain after 15 min of surgery (0, 20 ± 2.00; -0.12 ± 2.53,), 30 min (0.96 ± 2.38; 0.92 ± 2.81), 1 h (-0.4 ± 1.42; - 0.60 ± 2.64), 2 h (0.52 ± 1.68; -0.16 ± 3.23), 4 h (-1.0 ± 2.63; -0.40 ± 3.09) and 6 h (-1.28 ± 2.18; -1.04 ± 2.54). The placebo effect had an influence on the results, in the second surgical moment, regardless of being in the placebo group and active treatment. A significant difference was observed in relation to pain scores for patients on active treatment (p = 0.013), who reported less pain, 30 minutes after surgery (0.94 ± 2.58) when compared to the placebo group. However, in the sixth hour (-1.16 ± 2.35) it was observed that individuals who took a placebo reported less pain perception (p = 0.0010) when compared to the group treated with the active principle. As a conclusion of the study, the pharmaceutical forms studied, through the application of the visual analog scale, showed a significant reduction in clinical pain parameters 30 minutes after administration, and were effective in controlling postoperative pain in surgery to remove lower third molars.