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

Mallinckrodt

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Hysterectomy

Treatments

Drug: IV Acetaminophen

Drug: IV Placebo 100 mL solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00399568

CPI-APA-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

331 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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