Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery

NCT01608308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-10-16

Study results available
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Summary

The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system.

Conditions

  • Chronic Sinusitis

Interventions

DRUG

IV Acetaminophen

1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

DRUG

Placebo

100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY
  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Davide Cattano, MD, PhD · The University of Texas Health Sciences Center at Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT01608308 on ClinicalTrials.gov