title: Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following orthopedic surgery: A pooled analysis of randomized, controlled trials.
abstract: OBJECTIVE
  To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (i.v.) patient-controlled analgesia (PCA).
  
  
  METHODS
  Acute Care Hospital.
  
  
  METHODS
  Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine i.v. PCA for postoperative pain in hospitalized postoperative patients. A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment.
  
  
  METHODS
  A total of 590 patients received fentanyl ITS (40 µg/dose) and 626 patients received morphine i.v. PCA (1 mg/dose) for up to 72 hours.
  
  
  METHODS
  Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control.
  
  
  RESULTS
  Patients had a mean age of about 60 years, were predominantly Caucasian (90.5 percent), and the majority underwent hip replacement (80.3 percent). There were more patients treated with fentanyl ITS who rated their pain control method as "excellent" compared to morphine i.v. PCA at 24 hours postsurgery (44.8 percent vs 33.0 percent, respectively; p < 0.001), 48 hours (37.5 percent vs 25.3 percent, respectively; p < 0.001), and at the last assessment (54.3 percent vs 39.6 percent, respectively; p < 0.001). There were more investigators who rated treatment with fentanyl ITS as "excellent" compared to morphine i.v. PCA at the last assessment (57.4 percent vs 36.9 percent, respectively; p < 0.001).
  
  
  CONCLUSIONS
  Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as "excellent" on the PGA and IGA assessments with fentanyl ITS than with morphine i.v. PCA.
authors.affiliation: Professor, Anesthesiology, Beaumont Health System, Troy, Michigan.
authors.forename: Craig T
authors.initials: CT
authors.lastname: Hartrick
authors.affiliation: Troy Orthopedic Associates, Troy, Michigan.
authors.forename: Donald M
authors.initials: DM
authors.lastname: Knapke
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Li
authors.initials: L
authors.lastname: Ding
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Hassan
authors.initials: H
authors.lastname: Danesi
authors.affiliation: formerly with The Medicines Company, Parsippany, New Jersey.
authors.forename: James B
authors.initials: JB
authors.lastname: Jones
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016058:Analgesia, Patient-Controlled; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D007478:Iontophoresis; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage*; D019637:Orthopedic Procedures; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine; D005283:Fentanyl