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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

Tracking Information
First Submitted Date  ICMJE November 17, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
Official Title  ICMJE Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fever
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: acetaminophen
    acetaminophen 15mg/kg (max 975mg)
    Intervention: Drug: Acetaminophen
  • Experimental: ibuprofen
    ibuprofen 10mg/kg (max 600mg)
    Intervention: Drug: Ibuprofen
  • Experimental: combination
    acetaminophen 15mg/kg (max 975mg) and ibuprofen 10mg/kg (max 600mg)
    Interventions:
    • Drug: Ibuprofen
    • Drug: Acetaminophen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 17, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02294071
Other Study ID Numbers  ICMJE LHRI IRF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Rieder, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael J Rieder, MD University of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP