An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Mo… (NCT00766506) | Clinical Trial Compass
TerminatedPhase 4
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
Stopped: Product class one recall
United Kingdom108 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sin…
What they're measuring
1
Participant's Evaluation of Mean Ability to Mobilize After Surgery