Status:
COMPLETED
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Lead Sponsor:
Mallinckrodt
Conditions:
Postoperative Pain
Hysterectomy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00399568
Start Date
November 1 2006
End Date
September 1 2007
Last Update
October 21 2016
Active Locations (27)
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1
University of Alabama (Anesthesiology)
Birmingham, Alabama, United States, 35249
2
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
3
Arizona Research Center, Inc (JC Lincoln)
Phoenix, Arizona, United States, 85023
4
Arizona Research Center, Inc. (Arrowhead)
Phoenix, Arizona, United States, 85023