title: A split-mouth, randomized, triple-blind, placebo-controlled study to analyze the pre-emptive effect of etoricoxib 120 mg on inflammatory events following removal of unerupted mandibular third molars.
abstract: Pain after third molar extraction has been considered the most suitable pharmaceutical model to evaluate acute pain. This study aimed to evaluate the pre-emptive analgesic/anti-inflammatory efficacy of etoricoxib 120 mg following mandibular third molar surgery. A split-mouth, randomized, triple-blind, placebo-controlled study was conducted with patients undergoing the surgical removal of mandibular third molars. All volunteers were allocated randomly to receive either etoricoxib 120 mg or placebo 1h preoperatively, and inflammatory events were evaluated. An estimated sample of 18 surgical units per group was required based on a pilot study (95% confidence level and 80% statistical power). Rescue medication was analyzed by Kaplan-Meier method through log-rank Mantel-Cox test and Pearson linear correlation (P<0.05). Pre-emptive etoricoxib reduced postoperative pain scores significantly in comparison to placebo (P<0.001), with a pain score peak at 6h after surgery (P<0.001). The mean rescue medication consumption was lower in the etoricoxib group compared to the placebo group over the study period (P<0.05). There was no statistically significant difference between groups related to swelling and trismus. The pre-emptive administration of etoricoxib 120 mg significantly reduced the postoperative pain intensity and the need for rescue medication, but did not reduce swelling or trismus.
authors.affiliation: Division of Oral Surgery, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: fwildson@yahoo.com.br.
authors.forename: F W G
authors.initials: FW
authors.lastname: Costa
authors.affiliation: Division of Oral Surgery, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: E C S
authors.initials: EC
authors.lastname: Soares
authors.affiliation: Post-graduate Program in Dentistry, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: D F S
authors.initials: DF
authors.lastname: Esses
authors.affiliation: Post-graduate Program in Dentistry, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: P G deB
authors.initials: PG
authors.lastname: Silva
authors.affiliation: Division of Oral Surgery, Walter Cantidio University Hospital, Fortaleza, Ceará, Brazil.
authors.forename: T P
authors.initials: TP
authors.lastname: Bezerra
authors.affiliation: Division of Oral Surgery, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil; Division of Clinical Pharmacology, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: H C
authors.initials: HC
authors.lastname: Scarparo
authors.affiliation: Division of Clinical Dentistry, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: T R
authors.initials: TR
authors.lastname: Ribeiro
authors.affiliation: Division of Clinical Pharmacology, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil; Division of Paediatrics, School of Dentistry, Federal University of Ceará, Fortaleza, Ceará, Brazil.
authors.forename: C S R
authors.initials: CS
authors.lastname: Fonteles
mesh_terms: D000293:Adolescent; D000328:Adult; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D008334:Mandible / Q000601:surgery*; D008964:Molar, Third / Q000601:surgery*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control*; D010919:Placebos; D011725:Pyridines / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D014081:Tooth Extraction; D014095:Tooth, Impacted / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D010919:Placebos; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib
keywords: etoricoxib; non-steroidal anti-inflammatory drugs; pre-emptive analgesia; third molar