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
This study has been terminated.
(Product class one recall)
Information provided by (Responsible Party):
First received: October 3, 2008
Last updated: March 14, 2013
Last verified: March 2013
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.
|Pain, Postoperative||Device: Fentanyl IONSYS Device: Morphine IV PCA||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge|
Resource links provided by NLM:
Further study details as provided by Janssen-Cilag Ltd.:
Primary Outcome Measures:
- Participant's Evaluation of Mean Ability to Mobilize After Surgery [ Time Frame: Hour 72 or early study withdrawal ]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).
Secondary Outcome Measures:
- Pain Intensity Numerical Rating Scale (NRS) [ 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) ]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.
- Nurse Ease of Care (EOC) Questionnaire Score [ Time Frame: When participant was fit for discharge (FFD) (assessed up to 91 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.
- Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control [ Time Frame: Hour 72 or early study withdrawal ]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 to Fit For Discharge (FFD) [ Time Frame: When participant was FFD (assessed up to 91 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.
- Number of Participants Who Require Rescue Medication [ Time Frame: Baseline up to Hour 3 ]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.
- Number of Participants Who Require Concomitant Antiemetic Medication [ Time Frame: Baseline up to end of study treatment (Hour 72) ]Antiemetic medicines are the drugs which prevent vomiting.
- Number of Participants Who Require Concomitant Non-opioid Analgesics [ Time Frame: Baseline up to end of study treatment (Hour 72) ]Non-opioid analgesics are non morphine like medications used to get relieve from pain.
Other Outcome Measures:
- Time to Actual Discharge [ Time Frame: When participant was actually discharged from ward care (assessed up to 258.5 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.
- Number of Participants Facing Technical Failure of the Device [ Time Frame: Baseline up to end of study treatment (Hour 72) ]Technical failure was defined as malfunctioning or failure of device to work appropriately.
|Study Start Date:||May 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Fentanyl IONSYS
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
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).
Active Comparator: Morphine IV PCA
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
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.
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00766506
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766506
|Belfast, United Kingdom|
|Cardiff, United Kingdom|
|Edinburgh, United Kingdom|
|Glasgow, United Kingdom|
|Liverpool, United Kingdom|
|Salford, United Kingdom|
|Solihull, United Kingdom|
Sponsors and Collaborators
|Study Director:||Janssen-Cilag Ltd. Clinical Trial||Janssen-Cilag Ltd.|