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

Postoperative Pain Clinical Trial

Official title:

Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399568
• Other study ID #: CPI-APA-301
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2006
• Last updated: May 14, 2015
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2015
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• IV Acetaminophen
Intravenous acetaminophen 1 g/100 mL
• IV Placebo 100 mL solution
IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)

Locations

Country	Name	City	State
United States	Albany Medical College Dept. of Anesthesiology	Albany	New York
United States	Allegheny Pain Managment	Altoona	Pennsylvania
United States	Arcadia Methodist Hospital	Arcadia	California
United States	University of Alabama (Anesthesiology)	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Jacobi Medical Center (Albert Einstein College of Medicine)	Bronx	New York
United States	Cooper Anesthesia	Camden	New Jersey
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	G and G Research, Inc.	Fort Pierce	Florida
United States	Glendale Adventist Medical Center	Glendale	California
United States	Century Clinical Research, INC	Holly Hill	Florida
United States	Memorial Herman/Memorial City Hospital	Houston	Texas
United States	Texas Woman's Hospital	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	University of Miami School of Medicine Dept. of Anesthesiology	Miami	Florida
United States	St. Peters University Hospital, Anesthesiology	New Brunswick	New Jersey
United States	Weill Medical College	New York	New York
United States	Huntington Memorial Hospital	Pasadena	California
United States	Thomas Jefferson University Dept. of Anesthesiology	Philadelphia	Pennsylvania
United States	Arizona Research Center, Inc (JC Lincoln)	Phoenix	Arizona
United States	Arizona Research Center, Inc. (Arrowhead)	Phoenix	Arizona
United States	Precision Trials	Phoenix	Arizona
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Accurate Clinical Trials, Inc.	San Clemente	California
United States	Helen Keller Hospital	Sheffield	Alabama
United States	Stony Brook Anesthesiology Health Sciences Cente	Stony Brook	New York
United States	Treasure Coast Obstetrics and Gynecology	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.	The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours.	Baseline (just prior to the first dose) through 24 hours	No
Primary	Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo	The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours.	Baseline (just prior to the first dose) through 48 hours	No
Secondary	Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)	First dose through 7 day follow up	Yes
Secondary	Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.	Number of subjects who reported SAEs during the study.; A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event	32 days following first dose of study medication.	Yes