Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Study Overview
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Brief Summary
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The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.

Official Title
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A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Conditions
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Fever

Intervention / Treatment
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* Drug: Diclofenac potassium
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study Exclusion Criteria: History of hypersensitivity to any drugs or excipients of the study Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding Neurological and hemodynamics disorders Evidence of liver or kidney impairment or heart failure Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours) Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac potassium<br> | Drug: Diclofenac potassium<br>* Diclofenac potassium<br>|
| Active Comparator: Acetaminophen<br> | Drug: Acetaminophen<br>* Acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Reduction of Temperature |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach a Reduction of Temperature as 0.5 and 1 °C |  | 2 hours | 
| Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours |  | 6 hours | 
| Safety of Diclofenac Potassium Therapy in the Study Period |  | 6 hours | 
| The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections