An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Fentanyl IONSYS; Morphine IV PCA
Intervention description: Participants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).; Morphine sulphate solution will be administered intravenously (IV) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
Intervention MeSH terms: Fentanyl; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IONSYS; Fentanyl; Morphine; PCA; Postoperative pain; Mobilization

Summary:

      The purpose of this study is to evaluate the mobilization characteristics, clinical use,
      safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled
      Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate
      (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in
      participants who have undergone elective major abdominal or orthopedic (pertaining to the
      bones) surgery.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants, after an elective major abdominal or orthopedic (pertaining to bones)
             surgery

          -  Expected to have acute (a quick and severe form of illness in its early stage)
             moderate (medium level of seriousness) to severe (very serious) post-operative pain
             requiring parenteral (administration by injection) opioids (morphine like medication)
             for at least 24 hours after surgery

          -  Participants who have undergone General anesthesia (loss of sensation or feeling),
             spinal anesthesia of less than or equal to 4 hours duration or epidural (outside the
             spinal cord) anesthesia

          -  Participants with respiratory rate 10 to 24 breaths per minute

          -  Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating
             Scale (NRS), after titration to comfort with intravenous (IV) morphine Exclusion
             Criteria

          -  Surgery secondary to malignancy (cancer or other progressively enlarging and spreading
             tumor) or trauma (injury)

          -  History of psychological opioid dependence and/or known or suspected to be opioid
             dependent

          -  Severe chronic (lasting a long time) obstructive respiratory symptoms susceptibility
             to respiratory depression, moderate to severe renal (having to do with the kidney)
             dysfunction

          -  Peri-operative administration of opioids other than morphine, fentanyl, sufentanil,
             alfentanil or remifentanil

          -  Require high doses of opioids to control their pain (more than 40 milligram morphine
             IV) during titration to comfort, or more than 6 hours have elapsed since the
             participant arrived in the recovery room or Monoamine oxidase inhibitors (MAOI) within
             14 days pre-study