A Phase 4 interventional study of Fentanyl IONSYS and Morphine IV PCA in Pain, Postoperative, sponsored by Janssen-Cilag Ltd.. Terminated at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-25.
Sponsored by Janssen-Cilag Ltd. · Phase 4, Interventional, and Treatment
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 (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.
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 told which treatment the participants are receiving), active-controlled (experimental treatment is compared to a standard treatment), parallel group study (a study comparing the response in two or more groups of participants receiving different treatments). 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. Eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 24 hours after an elective spine or elective orthopedic surgery) will be randomly assigned to receive either Ionsys or morphine IV PCA. Participants' safety will be monitored.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 108 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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Inclusion Criteria
Participants will receive 40 microgram (mcg) 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 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).
Device: Fentanyl IONSYS
Morphine sulphate solution will be administered intravenously (directly into the vein, IV) by a patient-controlled analgesia (PCA) pump using set bolus (a large amount) doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
Device: Morphine IV PCA
Participants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS).
Morphine sulphate solution will be administered intravenously (IV) 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
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).
Time frame: Hour 72 or early study withdrawal
Pain Intensity Numerical Rating Scale (NRS)
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.
Time frame: 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)
Nurse Ease of Care (EOC) Questionnaire Score
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.
Time frame: When participant was fit for discharge (FFD) (assessed up to 91 hours)
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
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?"
Time frame: Hour 72 or early study withdrawal
Time to Fit For Discharge (FFD)
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.
Time frame: When participant was FFD (assessed up to 91 hours)
Number of Participants Who Require Rescue Medication
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.
Time frame: Baseline up to Hour 3
Number of Participants Who Require Concomitant Antiemetic Medication
Antiemetic medicines are the drugs which prevent vomiting.
Time frame: Baseline up to end of study treatment (Hour 72)
Number of Participants Who Require Concomitant Non-opioid Analgesics
Non-opioid analgesics are non morphine like medications used to get relieve from pain.
Time frame: Baseline up to end of study treatment (Hour 72)
Time to Actual Discharge
The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.
Time frame: When participant was actually discharged from ward care (assessed up to 258.5 hours)
Number of Participants Facing Technical Failure of the Device
Technical failure was defined as malfunctioning or failure of device to work appropriately.
Time frame: Baseline up to end of study treatment (Hour 72)
| Milestone | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Started | 58 | 50 |
| Completed | 53 | 48 |
| Not completed | 5 | 2 |
| Withdrew: Use rescue medication after 3 hours | 3 | 0 |
| Withdrew: Other | 2 | 2 |
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).
| Units on scale | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Participant's Evaluation of Mean Ability to Mobilize After Surgery | 0.02 ± 0.101 | 2.26 ± 1.146 |
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.
| Unit on Scale | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Baseline (n = 58, 49) | 1.2 ± 1.76 | 1.3 ± 1.84 |
| Hour 1 (n = 58, 48) | 1.6 ± 2.36 | 1.5 ± 2.09 |
| Hour 2 (n = 57, 49) | 2.2 ± 2.51 | 2.1 ± 2.30 |
| Hour 3 (n = 57, 48) | 2.7 ± 2.28 | 2.2 ± 2.16 |
| Hour 4 (n = 57, 47) | 2.9 ± 2.20 | 2.9 ± 2.68 |
| Hour 5 (n = 58, 46) | 3.1 ± 2.25 | 2.5 ± 2.19 |
| Hour 6 (n = 55, 46) | 3.1 ± 2.12 | 2.5 ± 2.24 |
| Hour 8 (n = 54, 44) | 3.0 ± 1.86 | 2.3 ± 2.33 |
| Hour 12 (n = 48, 40) | 2.5 ± 2.03 | 1.8 ± 1.91 |
| Hour 24 (n = 52, 34) | 1.5 ± 1.69 | 1.9 ± 1.85 |
| Hour 48 (n = 13, 6) | 0.6 ± 0.96 | 1.5 ± 1.05 |
| Hour 72 (n = 3, 2) | 0.7 ± 1.15 | 0.5 ± 0.71 |
| Study discontinuation or withdrawal (n = 53, 50) | 1.8 ± 2.66 | 1.6 ± 1.78 |
| FFD (n = 44, 38) | 0.6 ± 1.06 | 1.3 ± 1.62 |
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.
| Units on scale | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Nurse Ease of Care (EOC) Questionnaire Score | 0.28 ± 0.399 | 0.80 ± 0.547 |
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?"
| Participants | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Poor | 5 | 1 |
| Fair | 1 | 6 |
| Good | 21 | 23 |
| Excellent | 31 | 19 |
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.
| Hours | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Time to Fit For Discharge (FFD) | 70.08 (65.50 to 72.25) | 71.21 (67.42 to 90.77) |
The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.
| Hours | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Time to Actual Discharge | 91.44 (75.33 to 96.50) | 94.61 (76.77 to 96.08) |
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.
| Participants | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Number of Participants Who Require Rescue Medication | 10 | 2 |
Antiemetic medicines are the drugs which prevent vomiting.
| Participants | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Dexamethasone | 1 | 0 |
| Cyclizine | 19 | 20 |
| Metoclopramide | 0 | 3 |
| Domperidone | 1 | 0 |
| Ondansetron | 11 | 12 |
| Granisetron | 2 | 2 |
| Mentha X Piperita | 0 | 1 |
Non-opioid analgesics are non morphine like medications used to get relieve from pain.
| Participants | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Paracetamol | 39 | 28 |
| NSAID's | 31 | 20 |
Technical failure was defined as malfunctioning or failure of device to work appropriately.
| Participants | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Number of Participants Facing Technical Failure of the Device | 1 | 1 |
Collected over From the time a signed informed consent form was obtained until the participant was discharged from ward care. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fentanyl IONSYS | — | 1/58 (1.7%) | 40/58 (69%) |
| Morphine IV PCA | — | 2/50 (4%) | 38/50 (76%) |
| Event | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| Wound infectionInfections and infestations | 1/58 | 1/50 |
| Femur fractureInjury, poisoning and procedural complications | 0/58 | 1/50 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/58 | 1/50 |
| HaematomaVascular disorders | 1/58 | 0/50 |
| Event | Fentanyl IONSYS | Morphine IV PCA |
|---|---|---|
| NauseaGastrointestinal disorders | 19/58 | 13/50 |
| HypotensionVascular disorders | 14/58 | 13/50 |
| VomitingGastrointestinal disorders | 4/58 | 6/50 |
| DizzinessNervous system disorders | 4/58 | 6/50 |
| BradycardiaCardiac disorders | 4/58 | 5/50 |
| DyspepsiaGastrointestinal disorders | 2/58 | 5/50 |
| ConstipationGastrointestinal disorders | 5/58 | 4/50 |
| PyrexiaGeneral disorders | 5/58 | 4/50 |
| Application site erythemaGeneral disorders | 5/58 | 0/50 |
| PainGeneral disorders | 5/58 | 0/50 |
| Age Continuous(Years) | Fentanyl IONSYS | Morphine IV PCA | Total |
|---|---|---|---|
| Mean | 58.4 ± 12.1 | 58.9 ± 11.8 | 58.7 ± 11.9 |
| Sex: Female, Male(Participants) | Fentanyl IONSYS | Morphine IV PCA | Total |
|---|---|---|---|
| Female | 33 | 33 | 66 |
| Male | 25 | 17 | 42 |
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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