Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00564486
First received: November 26, 2007
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).


Condition Intervention Phase
Pain
Drug: IV Placebo
Drug: IV Acetaminophen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain

Resource links provided by NLM:


Further study details as provided by Cadence Pharmaceuticals:

Primary Outcome Measures:
  • Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.) [ Time Frame: Baseline to 24 hrs ] [ Designated as safety issue: No ]
    Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with "100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period.


Secondary Outcome Measures:
  • Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.) [ Time Frame: Baseline to 24 hrs ] [ Designated as safety issue: No ]
    Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with "0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period.

  • The Number of Subjects Reporting a Treatment Emergent Adverse Event [ Time Frame: First dose through 7 day follow up ] [ Designated as safety issue: Yes ]

    Number of subjects who experienced at least one treatment emergent adverse event (TEAE).

    A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).


  • The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event [ Time Frame: First dose to 30 days after last dose of study medication. ] [ Designated as safety issue: Yes ]

    The number of subjects who reported at least one treatment emergent SAE during the study.

    A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded 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
    • is an important medical event


Enrollment: 244
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: IV Placebo 100 ml
IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
Drug: IV Placebo
IV, every 6 hours for 24 hours (4 doses total)
Other Name: placebo
Placebo Comparator: IV Placebo 65 ml
IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
Drug: IV Placebo
IV, every 4 hours for 24 hours (6 doses total)
Other Name: placebo
Experimental: IV Acetaminophen 1 gm
IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
Drug: IV Acetaminophen
IV, every 6 hours for 24 hours (4 doses total)
Other Names:
  • APAP
  • IV APAP
Experimental: IV Acetaminophen 650 mg
IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
Drug: IV Acetaminophen
IV, every 4 hours for 24 hours (6 doses total)
Other Names:
  • APAP
  • IV APAP

Detailed Description:

To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide written Informed Consent prior to participation in the Study
  • Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding, laparoscopic exploratory procedures in which no visceral dissection is performed, and laparoscopic procedures with minimal visceral dissection, such as laparoscopic sterilization,are excluded)
  • If Subject is a female of childbearing potential, have a negative pregnancy test within 21 days of surgery
  • Be at least 18, but not more than 80 years of age
  • Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2
  • Have an American Society of Anesthesiologist (ASA) risk class of I, II, or III
  • Have the ability to read and understand the Study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff
  • Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator, makes Study participation inadvisable

Exclusion Criteria:

  • Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
  • Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
  • Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
  • Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
  • Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years
  • Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alanine transaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit of normal, active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with Study Medication exposure
  • Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior to surgery
  • Has participated in another clinical Study (investigational or marketed product) within 30 days of surgery

Post Operative Exclusion Criteria

The Subject must not meet any of the following criteria prior to randomization to Study Medication:

  • Had any other surgery than the planned laparoscopic surgery or had intra operative or post operative complications which in the view of the Investigator would make Study participation inadvisable
  • Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during the day after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, for cardioprophylaxis, and limited use of topical or inhaled steroids are acceptable.
  • Had any neuraxial (spinal or epidural) opioid injected perioperatively
  • Had a local anesthetic injection (including into surgical wound at closure) or continuous infusion by any route
  • Had an epidural, regional, or percutaneous (intrawound) catheter with continuous local anesthetic infusion used for postoperative analgesic management
  • Had a fever (greater than 38.6 ºC or 101.5 ºF) requiring treatment

Post Operative Day 1 Randomization Criterion On the morning of the first post operative day (POD1), the Subject must have a categorical pain intensity score at rest of moderate or severe and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564486

Locations
United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
United States, California
Methodist Hospital
Arcadia, California, United States, 91007
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Physicians Clinical Research Corporation
Laguna Hills, California, United States, 92653
Huntington Memorial Hospital
Pasadena, California, United States, 91105
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33414
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
G and G Research, Inc.
Fort Pierce, Florida, United States, 34950
University of Miami School of Medicine
Miami, Florida, United States, 33136
Advanced Surgery Associates at Mercy Hospital
Miami, Florida, United States, 33133
United States, Michigan
William Beaumont Hospital (Royal Oak)
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital (Troy)
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, Texas
Texas Woman's Hospital
Houston, Texas, United States, 77024
Memorial Herman/Memorial City Hospital
Houston, Texas, United States, 77024
Sponsors and Collaborators
Cadence Pharmaceuticals
Investigators
Study Director: Mike Royal, MD, JD, MBA Cadence Pharmaceuticals
  More Information

No publications provided

Responsible Party: Mike Royal, VP Clinical Development, Analgesics, Cadence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00564486     History of Changes
Other Study ID Numbers: CPI-APA-304
Study First Received: November 26, 2007
Results First Received: September 25, 2009
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cadence Pharmaceuticals:
Abdominal Laparoscopic Surgery

Additional relevant MeSH terms:
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 18, 2014