Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266539
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-12-16
Brief Title:
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
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management After Non-emergent Abdominal or Pelvic Surgery
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients upper outer arm or chest that uses low-intensity electrical current to deliver fentanyl through the skin and into the patients bloodstream The patients studied will be those who have just had scheduled abdominal or pelvic surgery
Detailed Description:
The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled analgesia PCA PCA is a form of pain management that allows the patient to control the amount of pain medication he or she receives The PCA E-TRANS fentanyl system is a credit card-sized unit that is worn on the patients upper outer arm or chest It uses low-intensity electrical current to move fentanyl through the skin and into the patients bloodstream It does not require the insertion of an intravenous IV needle or injection for pain management PCA IV morphine is delivered into a vein by an IV infusion pump that is specially designed to be controlled by the patient The PCA E-TRANS fentanyl system delivers a 40 microgram dose of fentanyl and the PCA IV morphine delivers a 1 milligram intravenous dose of morphine The patients in this study are those scheduled for non-emergent abdominal or pelvic surgery Before surgery patients will be taught how to use both PCA devices and randomly assigned to receive either PCA IV morphine or E-TRANS fentanyl After undergoing surgery patients will have the PCA device applied to the skin E-TRANS fentanyl or an IV inserted into a vein PCA IV morphine according to the random assignment The patient will then be allowed to control delivery of the assigned medication for 72 hours During the first 24 hours the patient will be asked about the amount of pain he or she is having The primary measure of effectiveness is successful pain relief defined by a rating of Excellent or Good on the 24-hour patient global assessment of the method of pain control At 24 48 and 72 hours the patient will be asked a set of specific questions to measure the effectiveness of the PCA In addition the patients doctor and nurses will answer questions about the PCA system Safety will be assessed by monitoring the patients vital signs and recording any adverse events including problems at the location on the patients body where the PCA device has been applied or inserted The objective is to establish that the Fentanyl HCl Patient-Controlled Transdermal System E-TRANS fentanyl is as effective as intravenous IV PCA morphine in controlling pain after non-emergent abdominal or pelvic surgery
E-TRANS fentanyl 40 mcg transdermally per patient-activated dose over 10 minutes up to 6 doses per hour or a maximum of 80 doses in 24 hours Patient controlled intravenous morphine 1 mg dose up to 10 doses per hour or a maximum of 240 doses in 24 hours Study duration is 72 hours
E-TRANS fentanyl 40 mcg transdermally per patient-activated dose over 10 minutes up to 6 doses per hour or a maximum of 80 doses in 24 hours Patient controlled intravenous morphine 1 mg dose up to 10 doses per hour or a maximum of 240 doses in 24 hours Study duration is 72 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None