A Comparison of the Safety and Effectiveness of Two Forms of Patient-controlled Pain Medication Used After Scheduled Abdominal or Pelvic Surgery: The Fentanyl Transdermal System Versus the Morphine Intravenous Pump
NCT00266539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506
Last updated 2011-05-19
Summary
The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the patient's upper outer arm or chest that uses low-intensity electrical current to deliver fentanyl through the skin and into the patient's bloodstream. The patients studied will be those who have just had scheduled abdominal or pelvic surgery.
Conditions
- Pain, Postoperative
Interventions
- DRUG
-
E-TRANS Fentanyl hydrochloride; Morphine
Sponsors & Collaborators
-
PriCara, Unit of Ortho-McNeil, Inc.
collaborator INDUSTRY -
Alza Corporation, DE, USA
lead INDUSTRY
Principal Investigators
-
Alza Corporation Clinical Trial · Alza Corporation, DE, USA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Completion
- 2005-04-30
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