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

M

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

331 participants in 2 patient groups, including a placebo group

IV acetaminophen 1 g/100 mL solution
Experimental group
Treatment:
Drug: IV Acetaminophen
IV Placebo 100 mL solution
Placebo Comparator group
Treatment:
Drug: IV Placebo 100 mL solution

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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