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Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

NCT02832687 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-12-09

Study results available
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Summary

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.

Conditions

  • Recovery Following Cholecystectomy

Interventions

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.

DRUG

normal saline

100mL of normal saline every 4 hours to a maximum administration of 400mL

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Michal Gajewski, Do · Rutgers, State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2020-09-01
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832687 on ClinicalTrials.gov