Evaluation of the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal PCA system (Ionsys) and morphine IV PCA for management of acute moderate to severe post-operative pain in patients who have undergone elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty).
Conditions
Interventions
Trade Name: IONSYS
Product Name: IONSYS
Pharmaceutical Form: Iontophoretic transdermal system
INN or Proposed INN: Fentanyl Hydrochloride
Other descriptive name: FENTANYL HYDROCHLORIDE
Concentration u
Sponsors
Janssen-Cilag Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult, age 18 or older, male or female. 2.American Society of Anesthesiology (ASA) pre-operative physical status I or II (see Attachment 1 of the Protocol). 3.Patients, after an elective major abdominal surgery (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) who are expected to have acute moderate to severe post-operative pain requiring parenteral opioids via PCA for at least 24 hours after surgery. 4.Expected to remain hospitalised for at least 24 hours post-operatively. 5.Capable of understanding and co-operating with the requirements of the study and operating the Fentanyl ITS (Ionsys) system or the IV PCA device. 6.Have signed and dated an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 7. Have been admitted to the recovery room after:- -general anaesthesia -spinal anaesthetic of less than or equal to four hours' duration of action or -epidural anaesthesia during the protocol-specified elective major abdominal or orthopaedic procedure and who are expected to suffer from acute moderate to severe post-operative pain and will require parenteral analgesia for at least 24 hours. Patients with epidural or regional anaesthesia will only be included if the provided analgesia was short lasting and was only given for the period of surgery and not for the period in the recovery room. When entering the recovery room, patients with epidural or regional anaesthesia must still qualify for needing parenteral analgesia according to the local hospital standards. 8.Alert and breathing spontaneously for at least 30 minutes in the recovery room; respiratory rate 10 to 24 breaths per minute; SpO2 =95% (with or without supplemental oxygen), are able to answer questions and follow commands. 9.Have a pain score less than or equal to 4 out of 10 on a NRS after titration to comfort with IV morphine. In case of abdominal hysterectomy, this should be measured five minutes after deep breathing and coughing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Revision of a previous hip arthroplasty in patients who require orthopaedic surgery. 2. Major abdominal surgery (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) because of malignancy or trauma. 3. History of allergy or hypersensitivity to: -fentanyl -and/or morphine -and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride 4. History of psychological opioid dependence and/or known or suspected to be opioid dependent (defined as meeting any of the criteria for substance dependence specified in Attachment 2 of the Protocol) 5. Known to be opioid tolerant (in the opinion of the investigator) before entering the study. Previous medical and drug history should be considered in this respect. 6. Known or suspected to have a dependency on any drug substance or alcohol (see Attachment 3 of the Protocol). 7. Persistent somatoform pain disorder (ICD-10 code F45.4). 8. Active systemic skin disease or active local skin disease that precludes Ionsys application. 9. Known to have any of the following: -severe chronic obstructive respiratory symptoms; -susceptibility to respiratory depression (possible synergistic effect associated with CNS drugs) -moderate to severe renal dysfunction -a coexisting medical condition, (possibly with chronic pain of another organ) that is likely to interfere with study procedures. 10. Women who are pregnant, breast feeding, or planning to breast feed within 24 hours of the last dose of study drug. Women of childbearing potential must produce a negative pregnancy test on the day of admission. This does not apply to women scheduled for a hysterectomy. 11. Require postoperative treatment in the intensive care unit. 12. Have received peri-operative administration of opioids other than morphine, fentanyl, sufentanil, alfentanil or remifentanil. Exception: If there are no medical contraindications, one dose of pethidine (0.3-0.5 mg/kg IV) or tramadol (1 mg/kg IV) is allowed within 30 minutes of arrival in the recovery room to control post-operative shivering. 13. Need very high doses of opioids to control their pain (more than 40 mg morphine IV) during titration to comfort or more than 6 hours have elapsed since the patient arrived in the recovery room. 14. Use of monoamine oxidase inhibitors (MAO) within 14 days is not permitted (severe and unpredictable potentiation by MAOs has been reported with opioid analgesics). 15.Have previously enrolled in an Ionsys study. 16. Have taken any investigational drug or used an experimental medical device within 30 days before the start of the study or are currently enrolled in another investigational drug study. 17. Will probably require additional surgical procedures within 72 hours. 18. At the time of final screening assessments are intubated or have a laryngeal mask airway (LMA). 19.Employees of the investigator or the study centre, with direct involvement in the proposed study or other studies under the direction of the investigator or study centre, as well as family members of the employees of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of Ionsys over morphine IV PCA with regard to the patient's ability to mobilise during the management of acute moderate to severe post-operative pain. Ability to mobilise will be assessed through a combined analysis of patient responses to three validated questions: 1). Because of the system/device I had to be careful when I used my hands or arms (to eat, brush teeth or sit up in bed) 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 (to chair in room, to bathroom in room/ward, to hallway).;Secondary Objective: -To evaluate pain rating (on a scale of 0 to 10) using the Numerical Rating Scale (NRS). -To compare the safety of Ionsys in this surgical population with the safety of morphine IV PCA, as assessed by adverse events. -To compare the use of Ionsys in this surgical population with morphine IV PCA, as assessed by technical failures of the system/device. -To compare the impact on nursing care of each system by means of a validated Ease of Care (EOC) questionnaire. -To assess the Patient's Global Assessment (PGA) of the method of pain control at the end of study treatment. -To evaluate differences in time taken for the patient to become ‘Fit For Discharge’ (FFD) according to common medical and nursing criteria. -To evaluate the impact of pre-operative medication and intra-operative anaesthetic procedures on time taken to achieve fitness for discharge in both treatment groups. Please refer to Protocol for further information.;Primary end point(s): The primary efficacy endpoint is the patient’s evaluation of their ability to mobilise. post-operatively. Assessments will be hourly during the first 6 hours. If the patient is still receiving study treatment, further assessments will be made at hours 8, 12, 24, 48 and 72 hours after application of Ionsys or enablement of the | — |
Countries
United Kingdom
Outcome results
None listed