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Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

This study is currently recruiting participants.
Verified June 2017 by Michal Gajewski, DO, Rutgers, The State University of New Jersey
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832687
First Posted: July 14, 2016
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Michal Gajewski, DO, Rutgers, The State University of New Jersey
  Purpose
Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose IV acetaminophen on patients' readiness for discharge. In doing so the investigators will also investigate the various factors that could potentially contribute to a patient's readiness for discharge such as overall opioid consumption, time to rescue medication, incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers and their overall correlation with IV acetaminophen intake.

Condition Intervention Phase
Recovery Following Cholecystectomy Drug: Acetaminophen Drug: normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multi-center, Randomized, Double-blind, Pilot Study on the Effect of Intravenous Multi-dose Acetaminophen on Readiness for Discharge in Patients Undergoing Surgery With General Anesthesia

Resource links provided by NLM:


Further study details as provided by Michal Gajewski, DO, Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • proportion of patients achieving discharge-readiness status at end of 2- hours post-surgery. [ Time Frame: 2 hours following surgery ]

Secondary Outcome Measures:
  • post operative pain scores [ Time Frame: pain scored every 15 min for 2 hours and then every 4 hours through study completion approximately 24 hours ]
  • Concentration of the plasma stress markers including cortisol, C Reactive Protein, [ Time Frame: preoperatively,prior to incision and at first hour in post anesthesia care unit (PACU) ]
  • time to rescue pain medication [ Time Frame: arrival in PACU to two hours post arrival first rescue medication ]
  • total dosage of post operative opioids [ Time Frame: from arrival in PACu until study completion average 24 hours ]
  • patient satisfaction survey [ Time Frame: prior to hospital discharge until study completion average 24 hours ]
  • incidence of post operative nausea [ Time Frame: from arrival in PACU until study completion average 24 hours ]
  • incidence of post-operative vomiting [ Time Frame: from arrival in PACU until study completion average 24 hours ]
  • need for additional antiemetics [ Time Frame: from arrival in PACU until study completion average 24 hours ]
  • concentration of sympathetic response: epinephrine and norepinephrine ; epinephrine and nor-epinephrine plasma concentrations [ Time Frame: preoperatively, prior to incision and first hour in PACU ]

Estimated Enrollment: 90
Actual Study Start Date: June 19, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: normal saline
Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.
Drug: normal saline
100mL of normal saline every 4 hours to a maximum administration of 400mL
Other Name: placebo
Experimental: acetaminophen
Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline
Drug: Acetaminophen
patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.
Other Name: Ofirmev

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing ambulatory laparoscopic cholecystectomy.
  • American Society of Anesthesiologists physical status 1, 2 or 3.-

Exclusion Criteria -

  • Cognitively impaired (by history) and unable or unwilling to consent
  • Chronic steroid or opioid user (as prescribed for a chronic systemic illness)
  • Parturient or nursing mother. Patients who have been informed by a physician that they have liver or kidney disease
  Contacts and Locations
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): NCT02832687


Contacts
Contact: Michal Gajewski, DO 973 972 5007 mg1214@njms.rutgers.edu
Contact: Catherine Schoenberg, BSN 973 972 7477 shoenbce@njms.rutgers.edu

Locations
United States, New Jersey
New Jersey Medical School Not yet recruiting
Newark, New Jersey, United States, 07103
Contact: Michal Gajewski, DO    973-972-5007    mg1214@njms.rutgers.edu   
University Hospital Not yet recruiting
Newark, New Jersey, United States, 07103
Contact: Michal Gajewski, DO    973-972-2128    mg1214@njms.rutgers.edu   
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Joel Yarmush, MD, MPA    718-780-5945    jmy@aol.com   
Principal Investigator: Joel Yarmush, MD, MPA         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Mallinckrodt
Investigators
Principal Investigator: Michal Gajewski, Do Rutgers, State University of New Jersey
  More Information

Responsible Party: Michal Gajewski, DO, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02832687     History of Changes
Other Study ID Numbers: 20150002613
First Submitted: May 24, 2016
First Posted: July 14, 2016
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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