Trial Outcomes & Findings for 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 (NCT NCT00766506)
NCT ID: NCT00766506
Last Updated: 2013-04-25
Results Overview
The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
Hour 72 or early study withdrawal
Results posted on
2013-04-25
Participant Flow
Participant milestones
| Measure |
Fentanyl IONSYS
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS \[a device which uses an electric current to move drug through the skin into the blood\]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
50
|
|
Overall Study
COMPLETED
|
53
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Fentanyl IONSYS
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS \[a device which uses an electric current to move drug through the skin into the blood\]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Overall Study
Use rescue medication after 3 hours
|
3
|
0
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.4 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
58.7 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 72 or early study withdrawalPopulation: The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Participant's Evaluation of Mean Ability to Mobilize After Surgery
|
0.02 Units on scale
Standard Deviation 0.101 • Interval -0.19 to 0.47
|
2.26 Units on scale
Standard Deviation 1.146 • Interval 1.98 to 2.76
|
SECONDARY outcome
Timeframe: Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Pain Intensity Numerical Rating Scale (NRS)
Baseline (n = 58, 49)
|
1.2 Unit on Scale
Standard Deviation 1.76
|
1.3 Unit on Scale
Standard Deviation 1.84
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 1 (n = 58, 48)
|
1.6 Unit on Scale
Standard Deviation 2.36
|
1.5 Unit on Scale
Standard Deviation 2.09
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 6 (n = 55, 46)
|
3.1 Unit on Scale
Standard Deviation 2.12
|
2.5 Unit on Scale
Standard Deviation 2.24
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 8 (n = 54, 44)
|
3.0 Unit on Scale
Standard Deviation 1.86
|
2.3 Unit on Scale
Standard Deviation 2.33
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 12 (n = 48, 40)
|
2.5 Unit on Scale
Standard Deviation 2.03
|
1.8 Unit on Scale
Standard Deviation 1.91
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 2 (n = 57, 49)
|
2.2 Unit on Scale
Standard Deviation 2.51
|
2.1 Unit on Scale
Standard Deviation 2.30
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 3 (n = 57, 48)
|
2.7 Unit on Scale
Standard Deviation 2.28
|
2.2 Unit on Scale
Standard Deviation 2.16
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 4 (n = 57, 47)
|
2.9 Unit on Scale
Standard Deviation 2.20
|
2.9 Unit on Scale
Standard Deviation 2.68
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 5 (n = 58, 46)
|
3.1 Unit on Scale
Standard Deviation 2.25
|
2.5 Unit on Scale
Standard Deviation 2.19
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 24 (n = 52, 34)
|
1.5 Unit on Scale
Standard Deviation 1.69
|
1.9 Unit on Scale
Standard Deviation 1.85
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 48 (n = 13, 6)
|
0.6 Unit on Scale
Standard Deviation 0.96
|
1.5 Unit on Scale
Standard Deviation 1.05
|
|
Pain Intensity Numerical Rating Scale (NRS)
Hour 72 (n = 3, 2)
|
0.7 Unit on Scale
Standard Deviation 1.15
|
0.5 Unit on Scale
Standard Deviation 0.71
|
|
Pain Intensity Numerical Rating Scale (NRS)
Study discontinuation or withdrawal (n = 53, 50)
|
1.8 Unit on Scale
Standard Deviation 2.66
|
1.6 Unit on Scale
Standard Deviation 1.78
|
|
Pain Intensity Numerical Rating Scale (NRS)
FFD (n = 44, 38)
|
0.6 Unit on Scale
Standard Deviation 1.06
|
1.3 Unit on Scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: When participant was fit for discharge (FFD) (assessed up to 91 hours)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Nurse Ease of Care (EOC) Questionnaire Score
|
0.28 Units on scale
95% Confidence Interval 0.399 • Interval 0.07 to 0.49
|
0.80 Units on scale
95% Confidence Interval 0.547 • Interval 0.55 to 1.05
|
SECONDARY outcome
Timeframe: Hour 72 or early study withdrawalPopulation: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: "Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?"
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=49 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Poor
|
5 Participants
|
1 Participants
|
|
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Fair
|
1 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Good
|
21 Participants
|
23 Participants
|
|
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Excellent
|
31 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: When participant was FFD (assessed up to 91 hours)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a "Yes" or "No" basis. When all criteria were answered as Yes, participant was considered to be FFD.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Time to Fit For Discharge (FFD)
|
70.08 Hours
Interval 65.5 to 72.25
|
71.21 Hours
Interval 67.42 to 90.77
|
SECONDARY outcome
Timeframe: Baseline up to Hour 3Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Number of Participants Who Require Rescue Medication
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study treatment (Hour 72)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
Antiemetic medicines are the drugs which prevent vomiting.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Ondansetron
|
11 Participants
|
12 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Granisetron
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Dexamethasone
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Cyclizine
|
19 Participants
|
20 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Metoclopramide
|
0 Participants
|
3 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Domperidone
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Require Concomitant Antiemetic Medication
Mentha X Piperita
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study treatment (Hour 72)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
Non-opioid analgesics are non morphine like medications used to get relieve from pain.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Number of Participants Who Require Concomitant Non-opioid Analgesics
Paracetamol
|
39 Participants
|
28 Participants
|
|
Number of Participants Who Require Concomitant Non-opioid Analgesics
NSAID's
|
31 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: When participant was actually discharged from ward care (assessed up to 258.5 hours)Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).
The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Time to Actual Discharge
|
91.44 Hours
Interval 75.33 to 96.5
|
94.61 Hours
Interval 76.77 to 96.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of study treatment (Hour 72)Population: Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.
Technical failure was defined as malfunctioning or failure of device to work appropriately.
Outcome measures
| Measure |
Fentanyl IONSYS
n=58 Participants
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 Participants
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Number of Participants Facing Technical Failure of the Device
|
1 Participants
|
1 Participants
|
Adverse Events
Fentanyl IONSYS
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Morphine IV PCA
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl IONSYS
n=58 participants at risk
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 participants at risk
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Vascular disorders
Haematoma
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
Other adverse events
| Measure |
Fentanyl IONSYS
n=58 participants at risk
Fentanyl 40 microgram (mcg) per 10 minutes 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 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
|
Morphine IV PCA
n=50 participants at risk
Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
5.2%
3/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Vascular disorders
Haematoma
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Vascular disorders
Wound haemorrhage
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
4/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Cardiac disorders
Bradycardia
|
6.9%
4/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
10.0%
5/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Nausea
|
32.8%
19/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
26.0%
13/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
4/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
12.0%
6/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Constipation
|
8.6%
5/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
8.0%
4/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
2/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
10.0%
5/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
2/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Haematemesis
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Pyrexia
|
8.6%
5/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
8.0%
4/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Application site erythema
|
8.6%
5/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Pain
|
8.6%
5/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Application site vesicles
|
3.4%
2/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Catheter Site pain
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Chest discomfort
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
General disorders
Inflammation of wound
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Infections and infestations
Infection
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Infections and infestations
Oral candidiasis
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Injury, poisoning and procedural complications
Wound secretion
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Investigations
Haemoglobin decreased
|
6.9%
4/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
8.0%
4/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Nervous system disorders
Dizziness
|
6.9%
4/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
12.0%
6/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Nervous system disorders
Syncope vasovagal
|
5.2%
3/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Nervous system disorders
Somnolence
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
8.0%
4/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Renal and urinary disorders
Haematuria
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
6.0%
3/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
4.0%
2/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
6.0%
3/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
2.0%
1/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Surgical and medical procedures
Perioperative analgesia
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Surgical and medical procedures
Spinal anaesthesia
|
1.7%
1/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
0.00%
0/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
|
Vascular disorders
Hypotension
|
24.1%
14/58 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
26.0%
13/50 • From the time a signed informed consent form was obtained until the participant was discharged from ward care
|
Additional Information
Study Responsible Physician
Janssen-Cilag Ltd. 50-100 Holmers Farm Way, High Wycombe , BUCKS, UK, HP12 4EG
Phone: +44 (0) 1494 567 444
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60