title: Efficacy of single-dose and multidose rofecoxib in the treatment of post-orthopedic surgery pain.
abstract: To determine the efficacy of rofecoxib in post-orthopedic surgery pain, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group trial. Two hundred eighteen patients enrolled. Day 1 patients received placebo, rofecoxib 50 mg, or naproxen sodium 550 mg. Days 2 through 5, the placebo and naproxen sodium groups received placebo, and the rofecoxib group received rofecoxib 25 or 50 mg. Rofecoxib 50 mg was superior to placebo (P < .05) and similar to naproxen sodium for all single-dose measures of pain relief. Days 2 through 5, the rofecoxib 50 mg group used less supplemental narcotic analgesia (P = .005) and reported less pain on global evaluations (P = .041) when compared with the placebo group; the efficacy of rofecoxib 25 mg fell between that of placebo and rofecoxib 50 mg for these endpoints (P < or = .267). Rofecoxib 50 mg once daily effectively treated post-orthopedic surgery pain.
authors.affiliation: Pulmonary and Immunology at Merck Research Laboratories, Rahway, New Jersey, USA.
authors.forename: A
authors.initials: A
authors.lastname: Reicin
authors.forename: J
authors.initials: J
authors.lastname: Brown
authors.forename: M
authors.initials: M
authors.lastname: Jove
authors.forename: J R
authors.initials: JR
authors.lastname: deAndrade
authors.forename: M
authors.initials: M
authors.lastname: Bourne
authors.forename: D
authors.initials: D
authors.lastname: Krupa
authors.forename: D
authors.initials: D
authors.lastname: Walters
authors.forename: B
authors.initials: B
authors.lastname: Seidenberg
mesh_terms: D000328:Adult; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage*; D008297:Male; D009288:Naproxen / Q000627:therapeutic use; D019637:Orthopedic Procedures; D010149:Postoperative Pain / Q000188:drug therapy*; D013450:Sulfones
chemical_list: D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D009288:Naproxen