Determine the Clinical Advantage of IV vs PO Acetaminophen

January 29, 2020 updated by: Yan Lai

Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA scores I-III
  • Ambulatory surgery patients
  • Ages 18-75
  • Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria:

  • Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
  • Known allergy to acetaminophen
  • Emergency surgery
  • Patients who were not fasted
  • Patients who cannot tolerate PO
  • Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
  • Pregnancy
  • Weight less than 50kg
  • Chronic daily narcotic use
  • Patients who's anesthetic plan requires regional anesthesia
  • Patient refusal to participate or do not have capacity to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Acetaminophen
Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
Drug: Saline
Intravenous saline
Drug: Oral Acetaminophen
oral acetaminophen 975mg pills
Active Comparator: Acetaminophen IV Soln
Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
Drug: Acetaminophen IV Soln
1000mg of IV acetaminophen
Drug: Placebo Pills
placebo match to acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PACU Visual Analogue Pain Scores
Time Frame: baseline, 1 hour, and Day 1 discharge
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
baseline, 1 hour, and Day 1 discharge
Total MME Intraoperatively
Time Frame: Day 1
Total Morphine Milligram Equivalent (MME) use intraoperatively
Day 1
Total Narcotic Use in PACU.
Time Frame: Day 1
Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PACU Length of Stay
Time Frame: up to 24 hours after PACU arrival
Time in PACU
up to 24 hours after PACU arrival
Patient Reported Total Narcotic Use Post-discharge
Time Frame: average 7 days
home opiod use
average 7 days
Patient Satisfaction.
Time Frame: 7 days post surgery
Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction
7 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yan Lai

Investigators

  • Principal Investigator: Yan Lai, MD, MPH, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 16-1763
  • IF#16-1763 (Other Identifier: Icahn School of Medicine at Mount Sinai)
  • IF#2175834 (Other Identifier: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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