Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children

November 17, 2014 updated by: Michael Rieder, Lawson Health Research Institute
This study will examine in detail the immediate effects of three common treatments given to children with fevers to lower their temperature. Each child will be given either ibuprofen, acetaminophen, or a combination, and their temperature monitored at five-minute intervals. The temperature-lowering effects of each treatment will be compared to evaluate which is most effective.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is no substantial evidence that a fever lower than 41°C is harmful to the welfare of an otherwise healthy child, although they can be dangerous to children already in critical condition [1,2]. However, fevers in healthy children commonly cause anxiety in parents and caregivers, so parents and physicians often give antipyretic medications to lower the fever [3,4]. Ibuprofen and acetaminophen are two of the most commonly used medications in children. Most major pediatric medical associations agree about appropriate dosages for children, but give no clear guidelines on whether ibuprofen or acetaminophen should be used [3,5]. Physicians commonly make the decision between the two based on their personal opinions of the efficacy and safety of the medications, or based on habit [6]. Survey data shows that more than half of physicians use combinations of both acetaminophen and ibuprofen to treat fever, either simultaneously or on an alternating schedule, with a variety of dosing patterns [6]. A majority of physicians believed there were established guidelines supporting this use, but in fact there are not [6].

Combining the two medications is widely theorized to improve effectiveness, but clinical trials comparing combination treatments to ibuprofen and/or acetaminophen alone have shown inconsistent results [4,7-12]. Several pharmacodynamic studies have shown that ibuprofen and acetaminophen both produce their largest effects on temperature within the first hour following dosage [9,10,13-16]. Despite this, only one study has been performed examining the change in temperature at intervals shorter than 30 minutes, and that study used substandard monitoring methods [10].

This study will use gold-standard monitoring methods to take temperatures every five minutes through the first one to four hours of treatment. Understanding the pattern of temperature change in the acute stages after dosing will help settle the debate about the optimal medication choice for treating childrens' fevers.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael J Rieder, MD
  • Phone Number: 58293 (519) 685-8500
  • Email: mrieder@uwo.ca

Study Contact Backup

  • Name: Lauren Faught, PhD
  • Phone Number: 519-661-3221
  • Email: lhanly2@uwo.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fever between 38 and 41 Celsius (inclusive) on presentation to ER
  • assessment by treating physician that patient requires antipyretic treatment

Exclusion Criteria:

  • known allergy or hypersensitivity to either study medication
  • received any antipyretic medication in past eight hours
  • patient requires admission to hospital
  • co-morbidities indicating increased risk of complication
  • assessment by treating physician that patient is medically unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetaminophen
acetaminophen 15mg/kg (max 975mg)
Drug: Acetaminophen
oral liquid acetaminophen 15mg/kg (max 975mg)
Other Names:
  • Tylenol
Experimental: ibuprofen
ibuprofen 10mg/kg (max 600mg)
Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Names:
  • Advil
Experimental: combination
acetaminophen 15mg/kg (max 975mg) and ibuprofen 10mg/kg (max 600mg)
Drug: Acetaminophen
oral liquid acetaminophen 15mg/kg (max 975mg)
Other Names:
  • Tylenol
Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Names:
  • Advil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
temperature reduction from baseline
Time Frame: 4 hours
change in temperature from baseline at time of drug administration and at five minute intervals afterward for a minimum of one hour, maximum 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Michael J Rieder, MD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHRI IRF (Other Grant/Funding Number: LHRI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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