Phase 3 Completed N=331 Randomized Quadruple-blind Treatment

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

Postoperative Pain · Hysterectomy

Source: ClinicalTrials.gov NCT00399568 ↗

Enrolled (actual)

331

Serious AEs

7.6%

Results posted

Dec 2010

Primary outcomePrimary: Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo. — 1793.3; 1845.3 units on a scale (in millimeters)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.	1793.3; 1845.3	—
PRIMARY Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo	3612.4; 3718.2	—
SECONDARY Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	141; 149	—
SECONDARY Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.	11; 14	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00399568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.