Fever, Pain
Conditions
Keywords
Pediatric (Birth to less than 6 months of age), Pain, Fever
Brief 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.
Detailed description
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.
Interventions
DRUGIbuprofen
Ibuprofen, 10 mg/kg
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, Open-label
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 4 hours | 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. |
| Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 4 hours | 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. |
| Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 4 hours | 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 to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 4 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred between 08-Aug2017 and 21-Feb2019. Subject were recruited were hospitalized pediatric subjects, aged birth (greater than 37 weeks gestational age) to less than six months of age, with a clinical indication of pain and fever.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen, 10 mg/kg
Ibuprofen: Ibuprofen, 10 mg/kg | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Able to be discharged | 3 |
| Overall Study | Wanted to use a restricted medication | 3 |
Baseline characteristics
| Characteristic | Ibuprofen |
|---|---|
| Age, Continuous | 127.7 days STANDARD_DEVIATION 33.77 |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Non-Latino | 19 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight | 6 kilograms STANDARD_DEVIATION 1.45 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 24 |
| other Total, other adverse events | 7 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | 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 | Standard Error 4.09 |
Primary
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
Population: Analysis were performed using sparse sampling concentration. Phoenix WinNonlin treats the sparse data as a special case of plasma concentration data. The NCA sparse methodology calculates PK parameters based on the mean profile for all the subjects in the dataset. Consequently, standard deviation can only be calculated based on observed data (AUC0-t and Cmax) but not on derived data (Tmax, T½ el.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen | Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 1.30 hours |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 56.28 microgram/milliliter | Standard Error 2.77 |
Primary
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
Population: Analysis were performed using sparse sampling concentration. Phoenix WinNonlin treats the sparse data as a special case of plasma concentration data. The NCA sparse methodology calculates PK parameters based on the mean profile for all the subjects in the dataset. Consequently, standard deviation can only be calculated based on observed data (AUC0-t and Cmax) but not on derived data (Tmax, T½ el.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen | Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | 10 minutes |