EFICÁCIA DO CETOROLACO E DO TRAMADOL/PARACETAMOL NO CONTROLE DA INTENSIDADE DA DOR PÓS-OPERATÓRIA EM CIRURGIA DE TERCEIROS MOLARES INCLUSOS

Abstract

The aim of the present study was to perform a systematic review and a randomized clinical trial with the objective of evaluating the efficacy of an anti-inflammatory and analgesics in the reduction of the postoperative pain intensity after impacted third molar surgery; and also to elaborate a measurement instrument that could quantify the patients' self-perception about discomfort in dentoalveolar surgeries. Three studies were carried out. Study 1, a systematic review; study 2, a clinical trial and study 3, the elaboration of a questionnaire to evaluate the patient's self-perception regarding the dental surgical procedure. The systematic review and meta-analysis (study 1) aimed to evaluate if ketorolac reduces the intensity of postoperative pain after impacted third molars surgery compared to the use of tramadol. A comprehensive search in the literature was performed, including only randomized trials comparing pain intensity after impacted third molar surgery in adult patients who used either ketorolac or tramadol for analgesia. Nine studies were included for qualitative analysis. Seven were judged as “unclear” or “high” risk of bias and only two judged as “low” risk of bias. We conclude that there is a lack of evidence to assure the superiority of ketorolac or tramadol in the reduction of postoperative pain after extraction of the impacted third molars. A randomized, triple-blind, crossover clinical trial (study 2) was conducted to compare the efficacy of ketorolac (K) versus its combination with tramadol (T)/acetaminophen (A) administered orally to control pain intensity after mandibular third molars surgery. Fifty-two patients were selected and subjected to extractions of bilateral mandibular third molars. Two different surgical interventions were performed, always by the same operator and separated by a minimum interval of 30 days. For the extraction of one side, the patient received one tablet of ketorolac 10 mg plus one capsule of tramadol 37.5 mg/acetaminophen 325 mg. For the opposite side, the same individual received one tablet of ketorolac 10 mg plus one capsule of placebo. These treatments were administered 1 h prior to surgery and were repeated every 6 h for 2 days. The difference in postoperative pain was assessed by four primary end points: pain intensity measured by a 100 mm visual analogue scale for 48 h (immediately, 3 h, 6 h, 9 h, 12 h, 24 h and 48 h after surgery), rescue medication, overall assessment and adverse effects. Differences in pain intensity were observed among the different time assessments (p < 0.05). The comparison of both groups in each time assessment showed significant differences only in the period of 9 h, with lower level of pain intensity for group K+T+A (p = 0.005). The need of analgesics was higher in Group K however, the need of antiemetic were greater in Group K+T+A. The total number of adverse effects was higher in Group K+T+A. The results showed that both pharmacological treatments had a good control of pain in mandibular third molar surgery. Although the combination group showed lower pain at 9 h, the difference is small, not clinically relevant and this group showed much more adverse effects. The aim of study 3 was to develop and validate a questionnaire (QCirDental) to measure the burdens of oral surgery associated to dental extractions. The QCirDental was developed in two steps, (1) item generation and selection and (2) questionnaire pretest with evaluation of the instruments’ measurement properties (internal consistency and responsiveness). The sample was composed by 123 patients. None patient showed any difficulty to understand the QCirDental. The instrument showed excellent internal consistency with Cronbach's alpha coefficient of reliability of 0.83. The principal component analysis (Kaiser-Meyer-Olkin 10 Measure of Sampling Adequacy 0.72 and Bartlett's Test of Sphericity with p < 0.001) showed six dimensions explaining 67.5% of the variance. In this study, it was possible to determine that the questionnaire of dento-alveolar oral surgery (QCirDental) has excellent internal consistency, being an instrument of easy reading and interpretation.