Phase 3
Completed N=118
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Source: ClinicalTrials.gov NCT01002573 ↗Enrolled (actual)
118
Serious AEs
4.0%
Results posted
Nov 2016
Primary outcomePrimary: Fever Reduction — -1.5; -0.9 degree Celsius*Time
◆ Published Evidence
Established
24citations · ~3 / year
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.
Summary
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fever Reduction |
-1.5; -0.9 | — |
| SECONDARY Change From Baseline in Temperature After the First 30 Minutes of Treatment |
-0.5; -0.3 | — |
| SECONDARY Change From Baseline in Temperature After the First 60 Minutes of Treatment |
-0.9; -0.5 | — |
| SECONDARY Change in Temperature |
-1.5; -0.9 | — |
| SECONDARY Change From Baseline in Temperature After the First Four Hours of Treatment |
-4.4; -2.6 | — |
| SECONDARY Time to Afebrility (in Hours) |
2.2; 3.3 | — |
| SECONDARY Number of Afebrile and Febrile Subject at 4 Hours Post-Dose |
43; 40; 3; 11 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01002573) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.