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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Acetaminophen; Analgesics; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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