A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Analgesia, Patient-controlled Pain, Postoperative |
Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem Drug: IV Morphine Patient-Controlled Analgesia (IV PCA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control |
- 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). ] [ Designated as safety issue: No ]
- Assessment of pain control by patient and doctor [ Time Frame: At 24, 48, and 72 hours after randomization ] [ Designated as safety issue: No ]
- Pain Intensity, vital signs, and oxygen level in the blood [ Time Frame: Hourly through 8 hours and then every 4 hours after randomization ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 657 |
| Study Start Date: | June 2004 |
| Study Completion Date: | April 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 001 |
Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
|
| Active Comparator: 002 |
Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)
20mg/2hr (240 mg during 24 hours)
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who meet the criteria of American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III
- Patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure
- Patients expected to remain hospitalized for at least 24 hours postoperatively
Exclusion Criteria:
- Known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives
- Known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol
- Severe respiratory symptoms
- Chronic pain disorder
- Pregnant or nursing women, or those lacking adequate contraception
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Global Medical Affairs Leader, Janssen-Cilag A.G. |
| ClinicalTrials.gov Identifier: | NCT00996177 History of Changes |
| Other Study ID Numbers: | CR003943, EuroTrans |
| Study First Received: | September 28, 2009 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Keywords provided by Janssen-Cilag International NV:
|
Pain Patient-controlled analgesia Postoperative pain |
Transdermal fentanyl Surgical pain Opioid analgesics |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Fentanyl Morphine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 21, 2013