Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Study Overview
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Brief Summary
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The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Detailed Description
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The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Official Title
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A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Conditions
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Fever

Intervention / Treatment
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* Drug: ibuprofen
* Drug: acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures. Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age. Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC). Exclusion Criteria: Have inadequate intravenous access. Have received antipyretic drug therapy within 2 hours before dosing. Have any history of allergy or hypersensitivity to NSAIDs or aspirin. Have received another investigational drug within the past 30 days. Be otherwise unsuitable for the study, in the opinion of the Investigator. Have a fever due to hyperthermia. Pregnant or nursing.

Ages Eligible for Study
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Maximum Age: 16 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen<br>Ibuprofen, 10 mg/kg | Drug: ibuprofen<br>* Ibuprofen, 10 mg/kg<br>|
| Active Comparator: Acetaminophen<br>Acetaminophen, 10mg/kg | Drug: acetaminophen<br>* Acetaminophen, 10mg/kg<br>* Other names: paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever Reduction | Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2) | 0 to 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Temperature After the First 30 Minutes of Treatment | Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment. | 30 minutes following treatment | 
| Change From Baseline in Temperature After the First 60 Minutes of Treatment | Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment. | 60 minutes following treatment | 
| Change in Temperature | Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment. | 4 hours following treatment | 
| Change From Baseline in Temperature After the First Four Hours of Treatment | Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4) | 0 to 4 hours post-dose | 
| Time to Afebrility (in Hours) | Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP. | 4 Hour post treatment | 
| Number of Afebrile and Febrile Subject at 4 Hours Post-Dose | Number of Afebrile and Febrile Subject at 4 Hours Following Treatment | 4 Hours Post-Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Fever