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Determine the Clinical Advantage of IV vs PO Acetaminophen

NCT03558555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-02-10

Study results available
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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.

Conditions

  • Inguinal Hernia

Interventions

DRUG

Acetaminophen IV Soln

1000mg of IV acetaminophen

DRUG

Oral Acetaminophen

oral acetaminophen 975mg pills

DRUG

Placebo Pills

placebo match to acetaminophen

DRUG

Saline

Intravenous saline

Sponsors & Collaborators

  • Yan Lai

    lead OTHER

Principal Investigators

  • Yan Lai, MD, MPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-12-30
Completion
2018-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03558555 on ClinicalTrials.gov