title: Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain.
abstract: This randomized, controlled trial compared the analgesic efficacy and safety of the new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) for the treatment of acute pain following oral surgery with double the dose of oxycodone alone (controlled-release [CR] oxycodone 20 mg [OxyContin]). A total of 150 male and female patients with > or = 2 full or partial bone-impacted mandibular molars, at least moderate persistent pain, and moderate trauma received a single dose of combination agent, CR oxycodone, or placebo following oral surgery and rated pain intensity and pain relief over the next 6 hours. The intent-to-treat population comprised 141 patients (55 on combination agent, 56 on oxycodone, and 30 on placebo). Combination agent and CR oxycodone were significantly superior to placebo for all efficacy measures. Combination agent was statistically superior to CR oxycodone in four of five outcome measures of pain intensity and pain relief (PPID, PPAR, SPID, and SPRID). It also provided a faster onset and 24% reduction in the number of patients reporting treatment-related adverse events compared with twice the dose of opioid alone. This new formulation offers the combination of two analgesic drugs with complementary mechanisms of action, which results in enhanced analgesia, an "opioid-sparing" effect, and an improved side effect and safety profile.
authors.affiliation: Endo Pharmaceuticals, Inc., 100 Painters Drive, Chadds Ford, PA 19317, USA.
authors.forename: Arnold R
authors.initials: AR
authors.lastname: Gammaitoni
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Galer
authors.forename: Scott
authors.initials: S
authors.lastname: Bulloch
authors.forename: Peter
authors.initials: P
authors.lastname: Lacouture
authors.forename: Frank
authors.initials: F
authors.lastname: Caruso
authors.forename: Tina
authors.initials: T
authors.lastname: Ma
authors.forename: Thomas
authors.initials: T
authors.lastname: Schlagheck
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019647:Oral Surgical Procedures / Q000009:adverse effects; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors
chemical_list: D000700:Analgesics; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D000082:Acetaminophen; D010098:Oxycodone