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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen | Experimental | Ibuprofen, 10 mg/kg |
|
| Acetaminophen | Active Comparator | Acetaminophen, 10mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen | Drug | Ibuprofen, 10 mg/kg |
| |
| acetaminophen |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, M.D. | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Loma Linda University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28143430 | Derived | Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Ibuprofen, 10 mg/kg ibuprofen: Ibuprofen, 10 mg/kg |
| FG001 | Acetaminophen | Acetaminophen, 10mg/kg acetaminophen: Acetaminophen, 10mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Acetaminophen, 10mg/kg |
|
|
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 |
| Loma Linda |
| California |
| 92354 |
| United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Howard University | Washington D.C. | District of Columbia | 20060 | United States |
| Jackson Memorial Hospital (U. Miami) | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Joseph M. Still Burn Center | Augusta | Georgia | 30909 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121-2483 | United States |
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| The Children's Hospital at Saint Francis | Tulsa | Oklahoma | 74136 | United States |
| LeBonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Treated Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen, 10 mg/kg ibuprofen: Ibuprofen, 10 mg/kg |
| BG001 | Acetaminophen | Acetaminophen, 10mg/kg acetaminophen: Acetaminophen, 10mg/kg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Mean | Standard Deviation | degree Celsius*Time | 0 to 2 hours post-dose |
|
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| ||||||||||||||||||||||||||||
| Secondary | 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. | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Mean | Standard Deviation | Celsius | 30 minutes following treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Mean | Standard Deviation | Celsius | 60 minutes following treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Temperature | Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment. | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Mean | Standard Deviation | Celsius | 4 hours following treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | 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) | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Mean | Standard Deviation | degree Celsius*Time | 0 to 4 hours post-dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Afebrility (in Hours) | Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP. | Posted | Mean | Standard Deviation | Hours | 4 Hour post treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Afebrile and Febrile Subject at 4 Hours Post-Dose | Number of Afebrile and Febrile Subject at 4 Hours Following Treatment | Some participants data was not included in the analysis due to having too few/insufficient data | Posted | Number | participants | 4 Hours Post-Dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen | Ibuprofen, 10 mg/kg ibuprofen: Ibuprofen, 10 mg/kg | 2 | 47 | 28 | 47 | ||
| EG001 | Acetaminophen | Acetaminophen, 10mg/kg acetaminophen: Acetaminophen, 10mg/kg | 2 | 53 | 22 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cardio-Respiratory Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Abdoimnal Abscess | Infections and infestations | Systematic Assessment |
| ||
| Transaminases Increased | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Blood Lactate Dehydrogenase Increased | Investigations | Systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Blood Albumin Decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
| ||
| Oxygen Saturation Decreased | Investigations | Systematic Assessment |
| ||
| Infusion Site Pain | General disorders | Systematic Assessment |
| ||
| Hypokaelmia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Operations | Cumberland Pharmaceuticals Inc. | 615-255-0068 | bkaelin@cumberlandpharma.com |
| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Title | Measurements |
|---|---|
|
| 6 years to 16 years |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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