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Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery

NCT03051932 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-02-05

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, placebo-controlled trial. A total of 100 patients, 50 per treatment arm, undergoing minimally invasive thoracic surgery will be randomized 1:1 across 2 treatment arms: Ofiramev® (acetaminophen) injection 1,000 mg (100 mL) plus patient-controlled analgesia (PCA) and 100 mL placebo plus PCA.

Conditions

  • Post-thoracotomy Pain Syndrome

Interventions

DRUG

Ofiramev® (IV Acetaminophen)

Post -op pain medication

DRUG

Placebo IV administration

Post -op pain

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Ikenna Okereke, MD · University of Texas Medical Branch at Galveston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-06-01
Completion
2019-06-01

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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 NCT03051932 on ClinicalTrials.gov