title: A comparison of opioid-related adverse events with fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia in acute postoperative pain.
abstract: OBJECTIVE
  This analysis compared opioid-related adverse events (ORADEs) observed with fentanyl iontophoretic transdermal system (ITS) versus morphine intravenous (iv.) patient-controlled analgesia (PCA) in the management of postoperative pain.
  
  
  METHODS
  Safety data from four Phase IIIB randomized, active-comparator trials were pooled for this analysis (n = 1288 fentanyl ITS and 1313 morphine iv. PCA patients). Treatment-emergent adverse events were collected via spontaneous report. In this post hoc analysis, ORADEs were defined as apnea, confusion, constipation, dyspnea, hypotension, hypoventilation, hypoxia, ileus, nausea, pruritus, somnolence, tachycardia, urinary retention and vomiting. Odds ratios (OR) and 95% CI were calculated for all ORADEs and p-values were based on logistic regression with treatment as effect.
  
  
  RESULTS
  There were fewer patients in the fentanyl ITS group compared with the morphine iv. PCA group who experienced at least one ORADE (52.7 vs 59.1%, respectively; OR: 0.772: 95% CI: 0.661-0.901; p = 0.0011). The ORADEs that occurred less frequently in the fentanyl ITS group than in the morphine iv. PCA group included hypotension (3.7 vs 5.5%, respectively; OR: 0.667; 95% CI: 0.459-0.969; p = 0.0338), hypoventilation (0.9 vs 1.9%, respectively; OR: 0.444; 95% CI: 0.217-0.906; p = 0.0256), nausea (40.3 vs 44.5%, respectively; OR: 0.842; 95% CI: 0.721-0.984; p = 0.0310), pruritus (5.5 vs 9.4%, respectively; OR: 0.559; 95% CI: 0.413-0.757; p = 0.0002) and tachycardia (1.6 vs 2.8%, respectively; OR: 0.489; 95% CI: 0.277-0.863; p = 0.0136). No ORADEs occurred more frequently in the fentanyl ITS group compared with the morphine iv. PCA group.
  
  
  CONCLUSIONS
  Fentanyl ITS, in the management of acute postoperative pain, offered safety advantages in terms of ORADEs compared with morphine iv. PCA.
authors.affiliation: Thomas Jefferson University, 111 South 11th Street, Gibbon Building, Philadelphia, PA 19107, USA.
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Viscusi
authors.affiliation: Klinikum Detmold-Lippe, RontegenstraBe/32756 Detmold, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Grond
authors.affiliation: The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Ding
authors.affiliation: The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
authors.forename: Hassan
authors.initials: H
authors.lastname: Danesi
authors.affiliation: Formerly of The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054, USA.
authors.forename: James B
authors.initials: JB
authors.lastname: Jones
authors.affiliation: West Haven VA Medical Center, 950 Campbell Avenue, West Haven, CT 06516, USA.
authors.forename: Raymond S
authors.initials: RS
authors.lastname: Sinatra
mesh_terms: D000081:Acetamides; D059787:Acute Pain / Q000188:drug therapy; D000279:Administration, Cutaneous; D061605:Administration, Intravenous / Q000009:adverse effects; D016058:Analgesia, Patient-Controlled / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000009:adverse effects*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007478:Iontophoresis / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects*; D010149:Postoperative Pain / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
chemical_list: D000081:Acetamides; D000701:Analgesics, Opioid; D009020:Morphine; C009158:CDAA; D005283:Fentanyl
keywords: fentanyl; iontophoretic transdermal system; morphine; opioid-related adverse drug events; patient-controlled analgesia; postoperative pain