Phase 4
Completed N=30
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Source: ClinicalTrials.gov NCT02583399 ↗Enrolled (actual)
30
Serious AEs
4.2%
Results posted
Nov 2020
Primary outcomePrimary: Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. — 75.74 mcg*hr/mL
◆ Published Evidence
Emerging
8citations · ~3 / year
A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.
Summary
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
Linked Publications
-
A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
75.74 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
56.28 | — |
| PRIMARY Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
1.30 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
- Have a clinical indication of pain or fever.
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.
Exclusion Criteria
- Have inadequate intravenous access.
- Have an uncorrected ductus dependent congenital heart disease.
- Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
- Have a current history of uncorrected hypovolemia or acute renal disease.
- Have a current history of acute liver disease.
- Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT02583399) 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.