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

This study has been completed.
Sponsor:
Collaborator:
Alza Corporation, DE, USA
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00996177
First received: September 28, 2009
Last updated: January 28, 2014
Last verified: January 2014
  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 4

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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996177

  Show 45 Study Locations
Sponsors and Collaborators
Janssen-Cilag International NV
Alza Corporation, DE, USA
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Publications:
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00996177     History of Changes
Other Study ID Numbers: CR003943, FEN-PPA-401, 2004-001201-10
Study First Received: September 28, 2009
Last Updated: January 28, 2014
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
Morphine
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 19, 2014