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A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously (EuroTrans)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996177
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : January 29, 2014
Alza Corporation, DE, USA
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Analgesia, Patient-Controlled Pain, Postoperative Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem Drug: IV Morphine Patient-Controlled Analgesia (IV PCA) Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control
Study Start Date : June 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IONSYS
IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
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: Patient-Controlled Analgesia
IV Morphine Patient-Controlled Analgesia (IV PCA)
Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)
20mg/2hr (240 mg during 24 hours)

Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. Assessment of pain control by patient and doctor [ Time Frame: At 24, 48, and 72 hours after randomization ]
  2. Pain Intensity, vital signs, and oxygen level in the blood [ Time Frame: Hourly through 8 hours and then every 4 hours after randomization ]
  3. Incidence of adverse events [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996177

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Wien, Austria
Brussel, Belgium
Gent, Belgium
Leuven, Belgium
Aalborg, Denmark
Kÿbenhavn Nv N/A, Denmark
Kÿbenhavn Ÿ, Denmark
Odense C, Denmark
Ÿrhus C, Denmark
Boulogne Billancourt Cedex, France
Le Kremlin Bicetre, France
Lille Cedex, France
Montpellier Cedex 5, France
Nice, France
Paris, France
Rennes Cedex 2, France
Suresnes, France
Aachen, Germany
Bochum, Germany
Bonn, Germany
Frankfurt / Main, Germany
Halle, Germany
Hamburg N/A, Germany
Jena, Germany
Kiel, Germany
Kÿln, Germany
Mainz, Germany
Marburg, Germany
Ulm, Germany
Cork, Ireland
Madrid, Spain
Göteborg, Sweden
Huddinge N/A, Sweden
Linköpng N/A, Sweden
Stockholm, Sweden
Örebro, Sweden
Genève, Switzerland
Luzern, Switzerland
St Gallen, Switzerland
Zuerich, Switzerland
Zurich, Switzerland
United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
N/a N/a, United Kingdom
Salford, United Kingdom
Sponsors and Collaborators
Janssen-Cilag International NV
Alza Corporation, DE, USA
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Publications of Results:
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Responsible Party: Janssen-Cilag International NV Identifier: NCT00996177    
Other Study ID Numbers: CR003943
FEN-PPA-401 ( Other Identifier: Janssen-Cilag International )
2004-001201-10 ( EudraCT Number )
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Janssen-Cilag International NV:
Patient-controlled analgesia
Postoperative pain
Transdermal fentanyl
Surgical pain
Opioid analgesics
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General