This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
331
Intravenous acetaminophen 1 g/100 mL
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours.
Time frame: Baseline (just prior to the first dose) through 24 hours
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours.
Time frame: Baseline (just prior to the first dose) through 48 hours
Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)
Time frame: First dose through 7 day follow up
Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event
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University of Alabama (Anesthesiology)
Birmingham, Alabama, United States
Helen Keller Hospital
Sheffield, Alabama, United States
Arizona Research Center, Inc (JC Lincoln)
Phoenix, Arizona, United States
Arizona Research Center, Inc. (Arrowhead)
Phoenix, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Arcadia Methodist Hospital
Arcadia, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Accurate Clinical Trials, Inc.
San Clemente, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
...and 17 more locations
Time frame: 32 days following first dose of study medication.