The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
357
15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
Eliza Coffee Memorial Hospital
Florence, Alabama, United States
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Shoals Medical Trials, Inc
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Lotus Clinical Research
Pasadena, California, United States
Thorton Hospital
San Diego, California, United States
Florida Research Associates, LLC
DeLand, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Pensacola Research Consultants, Inc
Pensacola, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
...and 6 more locations
Patient Global Satisfaction
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Time frame: 48 hours
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