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
Overview
- Phase
- Phase 3
- Intervention
- IV Placebo
- Conditions
- Pain
- Sponsor
- Mallinckrodt
- Enrollment
- 244
- Locations
- 17
- Primary Endpoint
- 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.)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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).
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.
Investigators
Eligibility 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:
Arms & Interventions
IV Placebo 100 ml
IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
Intervention: IV Placebo
IV Placebo 65 ml
IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
Intervention: IV Placebo
IV Acetaminophen 1 gm
IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
Intervention: IV Acetaminophen
IV Acetaminophen 650 mg
IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
Intervention: IV Acetaminophen
Outcomes
Primary Outcomes
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
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 Outcomes
- The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event(First dose to 30 days after last dose of study medication.)
- 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.)(Baseline to 24 hrs)
- The Number of Subjects Reporting a Treatment Emergent Adverse Event(First dose through 7 day follow up)