Pain, Postoperative
Conditions
Keywords
IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain
Brief 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.
Detailed description
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.
Interventions
DRUGFentanyl ITS
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.
Sponsors
Janssen Cilag N.V./S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 | 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. |
| Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48 | 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. |
| Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment | End of Study treatment (Hour 72) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control | Hour 72 or early withdrawal | 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? |
| Number of Participants With Nurse Global Assessment of Method of Pain Control | Hour 72 or early withdrawal | 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? |
| Number of Participants With Physician Global Assessment of Method of Pain Control | Hour 72 or early withdrawal | 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? |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fentanyl ITS Participants received 40 microgram (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 Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Prematurely Terminated | 13 |
Baseline characteristics
| Characteristic | Fentanyl ITS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
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
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Primary
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)
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Primary
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
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Secondary
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?
Time frame: Hour 72 or early withdrawal
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Secondary
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
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.
Secondary
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
Population: Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.