Patients who experience moderate to severe pain and required opioid analgesia for 24 hours immediately following non laparoscopic total abdominal hysterectomy surgery MedDRA version: 9.1 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
Trade Name: IONSYS 40 micrograms per dose iontophoretic transdermal system
Pharmaceutical Form: Iontophoretic transdermal system
INN or Proposed INN: Fentanyl HCL
CAS Number: 1443-54-5
Other descripti
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have signed an informed consent form, prior to any study procedures being done, indicating that they understand the purpose of and procedures required, for the study and are willing to participate in the study. 2. Patients who are adult females, 18 years of age or older. 3. Patients who have been admitted to Post Anesthesia Care Unit (PACU) after a general anesthesia with a surgical time of up to 4 hours for non-laparoscopic total abdominal hysterectomy. 4. Patients who are awake and breathing spontaneously; respiratory rate 8 to 24 breaths per minute, SpO2 > 90% (with or without supplemental oxygen). 5. Patients who have been in the PACU for at least 30 minutes, are alert, able to answer questions and follow commands, state they are comfortable (titrated with IV fentanyl as clinically appropriate) and report their pain is less than or equal to 4 on a scale of 0 (no pain) to 10 (worst possible pain). 6. Patients who are expected to remain hospitalized for at least 24 hours post-operatively. 7. Patients, who in the opinion of the investigator, are expected to have moderate or severe pain requiring parenteral opioids for at least 24 hours after surgery. 8. Patients who are capable of understanding and cooperating with the requirements of the study and operating the IONSYS™ system. 9. Patients who have an American Society of Anesthesiology (ASA) physical status of I, II or III (Appendix 4). 10. Patients who can understand and communicate in the local language. 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. Patients with a history of allergy, hypersensitivity, or intolerance to fentanyl, skin adhesives, and/or cetylpyridinium chloride. 2. Patients who received long acting intra-operative spinal anesthesia or epidural anesthesia for the surgery or who are expected to have post-operative analgesia supplied by a continuous regional technique or patient controlled epidural analgesia. 3. Patients who received local anesthesia in the surgical area. 4. Patients with a history of opioid dependence before the start of the study, defined as meeting any of the DSM-IV-TRÔ Criteria for Substance Dependence specified in Appendix 5. 5. Patients who have used any illicit drugs of abuse or abused alcohol within 30 days before the start of the study. 6. Patients with active systemic skin disease or active local skin disease that precludes IONSYSÔ system application. 7. Patients who are breastfeeding. 8. Patients who have a coexisting medical condition that is likely to interfere with study procedures. 9. Patients with a malignancy or with a history of malignancy within the past 5 years, except for a superficial squamous or basal cell carcinoma that has been treated with local excision and is no longer present. 10. Patients with a significant history (within the past 2 year) of bradyarrhythmias, acute or chronic pulmonary disease, sleep apnea [e.g., are on home continuous positive airway pressure, CPAP], impaired hepatic function, impaired renal function that may impair their reliable participation in the study or necessitate the use of medication not permitted in this study. 11. Patients with a history (within the past 6 months) of a major psychiatric disorder. 12. Patients with a history of suicidal ideation or suicidal attempts within the past two years. 13. Patients with severe hearing impairment. 14. Patients who in the opinion of the investigator should not be enrolled in the study because of precautions, warnings, or contraindications outlined in the E-TRANSâ fentanyl investigator’s brochure and/or fentanyl package insert. 15. Patients who are expected to require intensive care postoperatively. 16. Patients who will probably require additional surgical procedures within 24 hours. 17. Patients who receive intra- and/or post-operative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil or received long acting opioids. Exception: If there are no medical contraindications, meperidine up to 50mg IV is allowed while in PACU for shivering. 18. Patients who are intubated or have a laryngeal mask airway (LMA) at the time of final baseline assessments (at the time of IONSYSÔ application). 19. Patients who are known or suspected to be opioid tolerant. For the purposes of this study, a patient will be considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery, they have been taking short acting/short acting combination opioid analgesic greater than codeine 120 mg daily, hydrocodone 40 mg daily, tramadol 200 mg daily, or oxycodone 40 mg daily or if they are on any dose of strong opioid analgesic such as morphine, hydromorphone or fentanyl. 20. Patients with increased intracranial pressure. 21. Patients who have taken any investigational drug or used an investigational device within 30 days before the start of the study or are currently enrolled in another investigational drug or device study. 22. Patients who are unwilling or unable to abide by the requirem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the precise dosing pattern of IONSYS system use in post operative patients;Secondary Objective: To assess the feasibility of using the double stopwatch methodology for assessing time to onset of pain relief using the IONSYS system in post operative patients;Primary end point(s): As defined in protocol | — |
Countries
Belgium
Outcome results
None listed