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

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ClinicalTrials.gov Identifier: NCT02294071
Recruitment Status : Unknown
Verified November 2014 by Michael Rieder, Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Michael Rieder, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fever Drug: Ibuprofen Drug: Acetaminophen Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
Study Start Date : December 2014
Estimated Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: acetaminophen
acetaminophen 15mg/kg (max 975mg)
Drug: Acetaminophen
oral liquid acetaminophen 15mg/kg (max 975mg)
Other Name: Tylenol

Experimental: ibuprofen
ibuprofen 10mg/kg (max 600mg)
Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Name: Advil

Experimental: combination
acetaminophen 15mg/kg (max 975mg) and ibuprofen 10mg/kg (max 600mg)
Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Name: Advil

Drug: Acetaminophen
oral liquid acetaminophen 15mg/kg (max 975mg)
Other Name: Tylenol




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294071


Contacts
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Contact: Michael J Rieder, MD (519) 685-8500 ext 58293 mrieder@uwo.ca
Contact: Lauren Faught, PhD 519-661-3221 lhanly2@uwo.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Michael J Rieder, MD University of Western Ontario, Canada

Publications:
D Leduc SWCPSCPC. Temperature measurement in pediatrics. Canadian Pediatric Society. 2013.

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Responsible Party: Michael Rieder, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02294071     History of Changes
Other Study ID Numbers: LHRI IRF
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Michael Rieder, Lawson Health Research Institute:
acetaminophen
ibuprofen

Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Antipyretics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action