Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Cumberland Pharmaceuticals30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Fever

Interventions

IbuprofenDRUG

Ibuprofen, 10 mg/kg

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (4)

Kosair Charaties Pediatric Research Unit

Louisville, Kentucky, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.

Time frame: 4 hours

Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.

Time frame: 4 hours

Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.

Time frame: 4 hours

Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.

Time frame: 4 hours

Data from ClinicalTrials.gov

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