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Trial record 1 of 1 for:    NCT02369211
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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 : Recruiting
First Posted : February 23, 2015
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Richard D Urman, Brigham and Women's Hospital

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 PACU recovery times, inpatient hospital length of stay (LOS), patient satisfaction scores, postoperative pain scores, consumption of opiates as rescue agents and side effects, and costs associated with postoperative medications among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).

Condition or disease Intervention/treatment Phase
Prostatectomy Pain Drug: Acetaminophen (Ofirmev) Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
Study Start Date : September 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous acetaminophen
Patient receives 1g intravenous acetaminophen after the incision
Drug: Acetaminophen (Ofirmev)
Other Name: Ofirmev

Placebo Comparator: Placebo
Patient receives saline injection instead of the study drug
Drug: Placebo



Primary Outcome Measures :
  1. post anesthesia care unit length of stay [ Time Frame: approximately 30-90 min ]
  2. hospital length of stay [ Time Frame: 1-3 days ]
  3. Cost of analgesics used during hospital stay [ Time Frame: 1-3 days ]

Secondary Outcome Measures :
  1. Pain score [ Time Frame: 30-90 min ]
  2. Sedation score [ Time Frame: 30-90 min ]
  3. time to rescue medication [ Time Frame: 0-90 min ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing robotic-assisted laparoscopic prostatectomy
  • ≥18 years old males
  • ASA class 1-4

Exclusion Criteria:

  • Chronic opiate use
  • Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, ALT/AST 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369211


Contacts
Contact: Richard Urman, MD 6177328222 urmanr@gmail.com

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard Urman, MD    617-732-8222      
Contact: James Gosnell, RN    (617)732-8222    jgosnell@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Mallinckrodt
Investigators
Principal Investigator: Richard Urman, MD Brigham and Women's Hospital

Responsible Party: Richard D Urman, Assistant Professor of Anesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02369211     History of Changes
Other Study ID Numbers: 2014P002749
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard D Urman, Brigham and Women's Hospital:
acetaminophen

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