Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
- Conditions
- Postoperative PainHysterectomy
- Interventions
- Drug: IV Placebo 100 mL solution
- Registration Number
- NCT00399568
- Lead Sponsor
- Mallinckrodt
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 331
- Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
- 18-75 years of age
- Body Mass Index (BMI) between 19-45
- American Society of Anesthesiologists (ASA) risk class of I, II, III
- Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
- Moderate to Severe pain at rest
- Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
- Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
- Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
- Known history of alcohol or drug abuse or misuse
- Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
- Has significant medical disease(s), or conditions that may contraindicate participation in the study
- Has participated in another clinical trial within 30 days of surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV acetaminophen 1 g/100 mL solution IV Acetaminophen - IV Placebo 100 mL solution IV Placebo 100 mL solution -
- Primary Outcome Measures
Name Time Method Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. Baseline (just prior to the first dose) through 24 hours 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.
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo Baseline (just prior to the first dose) through 48 hours 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.
- Secondary Outcome Measures
Name Time Method Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event. 32 days following first dose of study medication. 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 eventSubjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) First dose through 7 day follow up 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)
Trial Locations
- Locations (27)
Stony Brook Anesthesiology Health Sciences Cente
🇺🇸Stony Brook, New York, United States
Allegheny Pain Managment
🇺🇸Altoona, Pennsylvania, United States
Weill Medical College
🇺🇸New York, New York, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Jacobi Medical Center (Albert Einstein College of Medicine)
🇺🇸Bronx, New York, United States
Thomas Jefferson University Dept. of Anesthesiology
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Herman/Memorial City Hospital
🇺🇸Houston, Texas, United States
Texas Woman's Hospital
🇺🇸Houston, Texas, United States
Accurate Clinical Trials, Inc.
🇺🇸San Clemente, California, United States
Arizona Research Center, Inc (JC Lincoln)
🇺🇸Phoenix, Arizona, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Arizona Research Center, Inc. (Arrowhead)
🇺🇸Phoenix, Arizona, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Arcadia Methodist Hospital
🇺🇸Arcadia, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Century Clinical Research, INC
🇺🇸Holly Hill, Florida, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
G and G Research, Inc.
🇺🇸Fort Pierce, Florida, United States
Treasure Coast Obstetrics and Gynecology
🇺🇸Vero Beach, Florida, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University of Miami School of Medicine Dept. of Anesthesiology
🇺🇸Miami, Florida, United States
Cooper Anesthesia
🇺🇸Camden, New Jersey, United States
St. Peters University Hospital, Anesthesiology
🇺🇸New Brunswick, New Jersey, United States
Albany Medical College Dept. of Anesthesiology
🇺🇸Albany, New York, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
University of Alabama (Anesthesiology)
🇺🇸Birmingham, Alabama, United States
Helen Keller Hospital
🇺🇸Sheffield, Alabama, United States