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Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

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ClinicalTrials.gov Identifier: NCT02369211
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Richard D Urman, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE February 17, 2015
First Posted Date  ICMJE February 23, 2015
Results First Submitted Date  ICMJE August 3, 2019
Results First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Post Anesthesia Care Unit Length of Stay [ Time Frame: approximately 30-240 min ]
    The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
  • Hospital Length of Stay [ Time Frame: 1-3 days ]
    This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Post Anesthesia Care Unit Length of Stay [ Time Frame: approximately 30-90 min ]
  • Hospital Length of Stay [ Time Frame: 1-3 days ]
  • Cost of analgesics used during hospital stay [ Time Frame: 1-3 days ]
Change History Complete list of historical versions of study NCT02369211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Pain Score [ Time Frame: 0-24 hours after surgery ]
    Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain). Mean pain score over first 24 hours postoperatively was collected.
  • Opioid Use [ Time Frame: 0-24 hours ]
    A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Pain Score [ Time Frame: 30-90 min ]
  • Sedation score [ Time Frame: 30-90 min ]
  • time to rescue medication [ Time Frame: 0-90 min ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Official Title  ICMJE Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
Brief Summary To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its potential to improve hospital efficiency and patient outcomes. The investigators compare the addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of opiates as rescue agents and side effects among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).
Detailed Description

Although IV acetaminophen has been studied in urologic surgery, it has not been studied specifically in prostatectomies, and therefore there are no outcomes or cost-effectiveness data currently available. In addition, the current trend is to perform prostatectomy with a robot-assisted laparoscopic technique to help minimize incision size, blood loss, postoperative pain, and speed up patient recovery. Current literature only includes the use of opioids in the perioperative setting for robot-assisted prostatectomy to treat pain, but only a small trial used oral acetaminophen as a measure for analgesia in RALP. In addition to the decreasing use of opioids in perioperative pain management, emphasis has been placed on reducing costs of healthcare. A major contributor to this issue is hospital length of stay (LOS) and there has been increased pressure on healthcare providers to decrease overall LOS. Several factors may contribute to hospital LOS, including hospital acquired infections, surgical recovery, wound care, other surgical and anesthesia-related complications, and importantly, inadequate pain control.

In this study we examine the impact of adding IV acetaminophen to the multimodal analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP). Our hypothesis is that the addition of IV acetaminophen can improve postoperative recovery time, inpatient LOS, postoperative pain scores, and opioid consumption.

This study specifically addresses pharmacoeconomics of IV acetaminophen. The goal is to understand its potential to improve hospital efficiency and patient outcomes. The study compares the impact of the addition of IV acetaminophen versus a placebo on postoperative anesthesia care unit recovery times, inpatient LOS, postoperative pain scores, consumption of opiates as rescue agents and side effects in patients undergoing RALP.

The study is a 2-arm, double-blind, randomized, placebo controlled trial comparing IV acetaminophen to a control (IV placebo). All patients in this study were scheduled to undergo RALP.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatectomy
  • Pain
Intervention  ICMJE
  • Drug: Acetaminophen (Ofirmev)
    The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
    Other Name: Ofirmev
  • Other: Placebo
    The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Study Arms  ICMJE
  • Experimental: Intravenous acetaminophen
    Patient receives 1g intravenous acetaminophen after the incision
    Intervention: Drug: Acetaminophen (Ofirmev)
  • Placebo Comparator: Placebo
    Patient receives saline injection instead of the study drug
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2019)
86
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
80
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing robotic-assisted laparoscopic prostatectomy
  • ≥18 years old males
  • American Society of Anesthesiologists class 1-4

Exclusion Criteria:

  • Chronic opiate use
  • Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
  • Allergy/hypersensitivity to acetaminophen
  • Patients with baseline dementia
  • Chronic diathesis
  • Chronic kidney disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02369211
Other Study ID Numbers  ICMJE 2014P002749
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard D Urman, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Richard Urman, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP