Pain Clinical Trial
— EuroTransOfficial title:
Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control
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.
Status | Completed |
Enrollment | 657 |
Est. completion date | April 2005 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag International NV | Alza Corporation, DE, USA |
Austria, Belgium, Denmark, France, Germany, Ireland, Spain, Sweden, Switzerland, United Kingdom,
Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment | 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). | No | |
Secondary | Assessment of pain control by patient and doctor | At 24, 48, and 72 hours after randomization | No | |
Secondary | Pain Intensity, vital signs, and oxygen level in the blood | Hourly through 8 hours and then every 4 hours after randomization | No | |
Secondary | Incidence of adverse events | Throughout study | No |
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