Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag N.V./S.A.
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Participants who will undergo elective spine or orthopedic (related to bones) surgery

• Participants who are expected to have moderate (medium level of seriousness) or severe (very serious) pain requiring parenteral (given by injection) opioids (morphine like medications) for at least 48 hours after surgery

• Participants who have been admitted to the Post Anesthesia Care Unit (PACU) after general anesthesia, spinal anesthetic of less than 4 hours duration of action or epidural (outside the spinal cord) anesthesia

• Participants who are alert and breathing spontaneously for at least 30 minutes in the PACU

• Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures

Exclusion Criteria:

• Participants with active systemic skin disease or active local skin disease that prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS) application

• Participants with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride

• Participants who received regular treatment with transdermal strong opioids within 14 days prior to surgery

• Participants who are known or suspected to have abused any drug substance or alcohol

• Participants who will probably require additional surgical procedures within 72 hours