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.
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids \[morphine like medications\] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.
Unnamed facility
Aalst, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Edegem, Belgium
Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24
Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Time frame: Hour 24
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Time frame: Hour 48
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Time frame: End of Study treatment (Hour 72)
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Time frame: Hour 72 or early withdrawal
Number of Participants With Nurse Global Assessment of Method of Pain Control
The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
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Time frame: Hour 72 or early withdrawal
Number of Participants With Physician Global Assessment of Method of Pain Control
The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Time frame: Hour 72 or early withdrawal