Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
NCT ID: NCT00399568
Last Updated: 2016-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2006-11-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IV acetaminophen 1 g/100 mL solution
IV Acetaminophen
Intravenous acetaminophen 1 g/100 mL
IV Placebo 100 mL solution
IV Placebo 100 mL solution
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Interventions
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IV Acetaminophen
Intravenous acetaminophen 1 g/100 mL
IV Placebo 100 mL solution
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Locations
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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
G and G Research, Inc.
Ft. Pierce, Florida, United States
Century Clinical Research, INC
Holly Hill, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
University of Miami School of Medicine Dept. of Anesthesiology
Miami, Florida, United States
Treasure Coast Obstetrics and Gynecology
Vero Beach, Florida, United States
William Beaumont Hospital
Royal Oak, Michigan, 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
Weill Medical College
New York, New York, United States
Stony Brook Anesthesiology Health Sciences Cente
Stony Brook, New York, United States
Jacobi Medical Center (Albert Einstein College of Medicine)
The Bronx, New York, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Allegheny Pain Managment
Altoona, Pennsylvania, 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
Countries
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Other Identifiers
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CPI-APA-301
Identifier Type: -
Identifier Source: org_study_id
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