Safety and Efficacy of Acetaminophen in the Intensive Care Unit.

Summary

The intensive care unit (ICU) team needs to know what effects acetaminophen has in critically ill patients. Acetaminophen is better known as Tylenol. It is the drug given to reduce fever. Most research that has looked at how safe and effective this drug is, has been done with healthy people. Those studies tell us it is safe and works well to bring down fever.

This may not be true for the ICU patient. Some research found acetaminophen was not as good at reducing fever as expected in the ICU. Fever helps to fight infection so it may help patients get better, but it is also stressful. When you have fever, you to need more oxygen, and your heart beats faster. If you have a fever after brain injury, you are less likely to make a full recovery. In patients with brain injury, a weak heart or trouble breathing we should treat fever. If we can predict how well acetaminophen will reduce fever, we can decide if this drug is enough, or other treatments are also needed.

If you do not have problems with your brain, heart, or lungs, it is safe to not treat fever. When you give this drug to treat fever, the body cools itself by sweating, and bringing hot blood to the skin's surface. These changes do not affect healthy people. Research suggests ICU patients may be at risk for sudden drop in blood pressure.

Our study will answer 2 questions: 1) When acetaminophen is given to treat fever in ICU patients, are they more likely to have a drop in blood pressure? 2) How much will acetaminophen reduce fever in ICU patients? We will study ICU patients with a fever who can safely get, or not get this drug. This information will help us decide when and how to treat fever in the ICU.

Conditions

• Critical Illness
• Fever

Interventions

DRUG

Acetaminophen

one-time dose of acetaminophen 650mg given via the enteral route (via the gut)

DRUG

Placebo

one-time dose of placebo (identical capsule) given via the enteral route (via the gut)

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• William Henderson, PhD · University of British Columbia

• Vininder K Bains, BSN · Vancouver Coastal Health

• Martha Mackay, PhD · University of British Columbia

• Leanne Currie, PhD · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• Canada

Study Locations