title: Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model.
abstract: OBJECTIVE
  To evaluate the analgesic effects of etoricoxib and comparator agents on the second and third days after oral surgery.
  
  
  METHODS
  There were 588 patients initially randomized to placebo (n=46), etoricoxib 120 mg once daily (n=97), etoricoxib 90 mg once daily (n=191), ibuprofen 600 mg every 6 hours (n=192), and acetaminophen 600 mg/codeine 60 mg (A/C) every 6 hours (n=62) after third-molar extraction (≥2, ≥1 impacted) in a double-blind controlled trial. Patients were allowed flexible dosing on days 2 and 3; 46, 96, 190, 192, and 56 patients on placebo, etoricoxib 120 mg, etoricoxib 90 mg, ibuprofen, and A/C, respectively, continued to Day 2 of the study. Outcomes included Average and Worst Recall Pain Assessments (0 to 10 scale) and Global Assessments of Study Medication (0 to 4 scale). Rescue medication (acetaminophen 325 mg up to 4 times daily) usage was evaluated. Adverse experiences were collected and evaluated.
  
  
  RESULTS
  Average Pain Recall scores were lower than placebo for all active treatments on Day 2 but only for etoricoxib 120 and 90 mg on Day 3. Worst Pain Recall scores were lower than placebo for only etoricoxib 120 and 90 mg on Day 2; all treatment groups were similar on day 3. Rescue medicine was used on day 2 in 57% of placebo patients, whereas use in active treatments ranged from 18% to 23%; for Day 3, rescue was used in 22% of placebo patients, whereas use in active treatments ranged from 14% to 20%. Differences in mean Patient's Global Assessment of Study Medication scores were significant for etoricoxib versus placebo (P<0.001) and for etoricoxib versus A/C (P<0.010). Nausea and vomiting were among the most common adverse events with higher frequency in the A/C group.
  
  
  CONCLUSIONS
  Pain control was most favorable for the etoricoxib doses and ibuprofen. Global Assessments of Study Medication continued to differentiate the treatments and demonstrated greater efficacy for etoricoxib on Days 2 and 3 compared with placebo and A/C (NCT00694369).
authors.affiliation: Jean Brown Research Inc., Salt Lake City, UT 84049, USA. jbrown@jeanbrownresearch.com
authors.forename: Jean D
authors.initials: JD
authors.lastname: Brown
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Daniels
authors.forename: Donald P
authors.initials: DP
authors.lastname: Bandy
authors.forename: Amy T
authors.initials: AT
authors.lastname: Ko
authors.forename: Arnold
authors.initials: A
authors.lastname: Gammaitoni
authors.forename: Anish
authors.initials: A
authors.lastname: Mehta
authors.forename: Judith A
authors.initials: JA
authors.lastname: Boice
authors.forename: Maria C
authors.initials: MC
authors.lastname: Losada
authors.forename: Paul M
authors.initials: PM
authors.lastname: Peloso
mesh_terms: D002985:Clinical Protocols; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D058492:Drug Repositioning; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D008964:Molar, Third / Q000601:surgery; D059408:Pain Management; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology*; D011725:Pyridines / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D014081:Tooth Extraction / Q000009:adverse effects*
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib