Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by the E-TRANS Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management After Primary Unilateral Total Hip Replacement
Sponsor study identifier
interventional
799
0 countries
N/A
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 2005
Actual (reported)The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled analgesia (PCA) 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 received a total hip replacement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
April 2005
Actual (reported)December 9, 2005
Actual (reported)December 13, 2005
Actual (reported)Success (defined by a rating of "Excellent", or "Good") on the 24-hour patient global assessment of the method of pain control.
Proportion of successes at 48 and 72 hours and at final assessment; mean pain intensity assessment at 24, 48, and 72 hours and at final assessment; mean scores from the Ramsay Sedation Scale.
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
E-TRANS Fentanyl hydrochloride; Morphine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
Alza Corporation Clinical Trial
Alza Corporation, DE, USA
799 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2005
First Posted
December 13, 2005
Study Start
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
April 2005
Actual (reported)Last Updated
May 19, 2011
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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