title: Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain.
abstract: OBJECTIVE
  The objective of this study was to compare the effectiveness of combination hydrocodone and ibuprofen with that of combination oxycodone and acetaminophen in the treatment of moderate to severe postoperative obstetric or gynecologic pain.
  
  
  BACKGROUND
  Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen.
  
  
  METHODS
  This randomized, double-blind, parallel-group, single-dose, active-comparator, placebo-controlled study compared the effects of a 2-tablet dose of hydrocodone 7.5 mg and ibuprofen 200 mg with those of a 2-tablet dose of oxycodone 5 mg and acetaminophen 325 mg and placebo. Analgesia was assessed over 8 hours.
  
  
  RESULTS
  Mean pain relief (PR) scores were similar for the hydrocodone with ibuprofen and oxycodone with acetaminophen groups (n = 61 and 59, respectively) at 0.5, 1, 1.5, 2, 2.5, 3, 4, and 7 hours and significantly greater for the hydrocodone with ibuprofen group at 5, 6, and 8 hours (P < or = 0.05). Mean pain intensity difference (PID) scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours and significantly greater for hydrocodone with ibuprofen at 5, 6, 7, and 8 hours (P < or = 0.05). Total PR scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3- and 0- to 4-hour intervals and significantly greater for hydrocodone with ibuprofen for the 0- to 6- and 0- to 8-hour intervals (P < 0.05). The sum of the PID scores was similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3-, 0- to 4-, 0- to 6-, and 0- to 8-hour intervals. The median estimated time to onset of analgesia, mean peak PR score, median time to remedication, and mean global assessment score were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen. Assay sensitivity was demonstrated by the presence of statistically significant differences between both active treatments and placebo (n = 60). The number of patients experiencing adverse events was similar for each of the 3 groups (11 [18.0%], hydrocodone with ibuprofen; 7 [11.9%], oxycodone with acetaminophen; and 6 [10.0%], placebo).
  
  
  CONCLUSIONS
  In this study, a 2-tablet dose of combination hydrocodone 7.5 mg and ibuprofen 200 mg was as effective as a 2-tablet dose of combination oxycodone 5 mg and acetaminophen 325 mg in the treatment of moderate to severe postoperative obstetric or gynecologic pain. Both treatments were superior to placebo. The results of this study suggest that the combination of hydrocodone 7.5 mg and ibuprofen 200 mg may offer prescribers an additional option in combination pain therapy.
authors.affiliation: Medical Affairs Department, Knoll Pharmaceutical Company, Mount Olive, New Jersey 07828-1234, USA. palangm@basf.com
authors.forename: M
authors.initials: M
authors.lastname: Palangio
authors.forename: G L
authors.initials: GL
authors.lastname: Wideman
authors.forename: M
authors.initials: M
authors.lastname: Keffer
authors.forename: C J
authors.initials: CJ
authors.lastname: Landau
authors.forename: E
authors.initials: E
authors.lastname: Morris
authors.forename: R T
authors.initials: RT
authors.lastname: Doyle
authors.forename: J G
authors.initials: JG
authors.lastname: Jiang
authors.forename: M
authors.initials: M
authors.lastname: Damask
authors.forename: A
authors.initials: A
authors.lastname: de Padova
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000284:Administration, Oral; D000328:Adult; D016362:Analgesia, Obstetrical / Q000379:methods; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000009:adverse effects; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D013607:Tablets
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D010919:Placebos; D013607:Tablets; D000082:Acetaminophen; D006853:Hydrocodone; D010098:Oxycodone; D007052:Ibuprofen