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
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.
Drug: E-TRANS Fentanyl hydrochloride; Morphine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Success (defined by a rating of "Excellent" or "Good") at 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.
|Study Start Date:||April 2004|
|Study Completion Date:||April 2005|
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 patient's upper outer arm or chest. It uses low-intensity electrical current to move fentanyl through the skin and into the patient's 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 patient's doctor, and nurses, will answer questions about the PCA system. Safety will be assessed by monitoring the patient's vital signs and recording any adverse events, including problems at the location on the patient's 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.