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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Collaborator: Alza Corporation, DE, USA
• Treatments: Fentanyl; Morphine

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