Status:
TERMINATED
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
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a randomized (study drug assigned by chance), multicentre (when more than one hospital or medical school team work on a medical research study), open-label (participants and physicians are tol...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00766506
Start Date
May 1 2008
End Date
September 1 2008
Last Update
April 25 2013
Active Locations (7)
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1
Belfast, United Kingdom
2
Cardiff, United Kingdom
3
Edinburgh, United Kingdom
4
Glasgow, United Kingdom