Determine the Clinical Advantage of IV vs PO Acetaminophen

Last updated: January 29, 2020
Sponsor: Yan Lai
Overall Status: Completed

Phase

4

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT03558555
GCO 16-1763
IF#16-1763
IF#2175834
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA scores I-III

  • Ambulatory surgery patients

  • Ages 18-75

  • Surgeries requiring general anesthesia for hernia surgery

Exclusion

Exclusion Criteria:

  • Patients with contraindications to acetaminophen (history of end organ liverdysfunction)

  • 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 Design

Total Participants: 103
Study Start date:
December 08, 2017
Estimated Completion Date:
December 30, 2018

Study 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.

Connect with a study center

  • Mount Sinai West Hospital

    New York, New York 10019
    United States

    Site Not Available

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