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Intravenous Acetaminophen in Craniotomy

NCT01598701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-19

Study results available
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Summary

The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.

Conditions

  • Postoperative Pain

Interventions

DRUG

Acetaminophen

Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

DRUG

Placebo

100 mL 0.9% Sodium Chloride

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Carlos A. Artime, MD · University of Texas Health Sciences Center at Houston

  • Sam D. Gumbert, MD · 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
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-02
Primary Completion
2016-03-30
Completion
2016-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01598701 on ClinicalTrials.gov