Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Postoperative Pain, Hysterectomy

In brief

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.

Key facts

Study ID

NCT00399568

Run by

Mallinckrodt

People needed

331

Starts

2006-11-01

Expected to finish

2007-09-01

Last updated by the study team

2016-10-21

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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