A Phase 4 interventional study of IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem and IV Morphine Patient-Controlled Analgesia (IV PCA) in Pain, Analgesia, Patient-Controlled and Pain, Postoperative, sponsored by Janssen-Cilag International NV. Completed at 45 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by Janssen-Cilag International NV · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.
This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-controlled analgesia (PCA) systems to deliver pain medication either through the skin or intravenously. The fentanyl hydrochloride PCA system, which delivers the medication through the skin, and morphine intravenous (IV)- PCA, which requires injection into a vein, are used for management of moderate to severe acute pain in postoperative patients who have undergone elective major abdominal or orthopedic surgery. These patients, who are expected to require postoperative pain relief with strong opioids for at least 24 hours, will control the delivery of medication for up to 3 days. Assessment of effectiveness include: patient's global assessment of pain control (poor, fair, good, excellent); Pain Intensity, measured on a visual numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain; Ease-of-Care questionnaires including Patient Ease-of-Care questionnaire, Nurse Ease-of-Care questionnaire, and Physical Therapist Ease-of-Care questionnaire; and, total number of doses delivered by patients in the fentanyl transdermal PCA or morphine IV PCA treatment groups. Safety evaluations include vital signs (pulse, blood pressure) and oxygen saturation, respiratory function, and the incidence of adverse events. The study hypothesis is that fentanyl transdermal PCA is not inferior to morphine IV PCA treatment in patient's global assessment of method of pain control during the first 24 hours after surgery. Transdermal PCA: 40 micrograms fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours (maximum of 80 doses, 3.2milligrams). Morphine IV PCA: morphine doses with a maximum of 20 milligrams per 2 hours for 24 hours (maximum 12 doses, 240 milligrams).
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 657 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Janssen-Cilag International NV is the lead sponsor of 66 studies on the registry; none are open to participants now.
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Exclusion Criteria:
IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
IV Morphine Patient-Controlled Analgesia (IV PCA)
Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)
40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
20mg/2hr (240 mg during 24 hours)
Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment
Time frame: 24 hours after randomization (24 hours after either the first transdermal iontorphoretic system was applied or 24 hours after the intravenous access for the morphine solution was applied).
Assessment of pain control by patient and doctor
Time frame: At 24, 48, and 72 hours after randomization
Pain Intensity, vital signs, and oxygen level in the blood
Time frame: Hourly through 8 hours and then every 4 hours after randomization
Incidence of adverse events
Time frame: Throughout study
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Janssen-Cilag International NV