This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).
To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
IV, every 6 hours for 24 hours (4 doses total)
IV, every 4 hours for 24 hours (6 doses total)
IV, every 6 hours for 24 hours (4 doses total)
Helen Keller Hospital
Sheffield, Alabama, United States
Precision Trials
Phoenix, Arizona, United States
Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with "100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period.
Time frame: Baseline to 24 hrs
Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with "0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period.
Time frame: Baseline to 24 hrs
The Number of Subjects Reporting a Treatment Emergent Adverse Event
Number of subjects who experienced at least one treatment emergent adverse event (TEAE). A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
Time frame: First dose through 7 day follow up
The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event
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IV, every 4 hours for 24 hours (6 doses total)
Methodist Hospital
Arcadia, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Physicians Clinical Research Corporation
Laguna Hills, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
G and G Research, Inc.
Ft. Pierce, Florida, United States
Advanced Surgery Associates at Mercy Hospital
Miami, Florida, United States
...and 7 more locations
The number of subjects who reported at least one treatment emergent SAE during the study. A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded 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 * is an important medical event
Time frame: First dose to 30 days after last dose of study medication.