Trial Outcomes & Findings for Pharmacokinetics of Ketamine in Infants and Children (NCT NCT00553839)
NCT ID: NCT00553839
Last Updated: 2016-02-08
Results Overview
pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model.
COMPLETED
NA
21 participants
5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
2016-02-08
Participant Flow
Participant milestones
| Measure |
Single Group Assignment
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Ketamine in Infants and Children
Baseline characteristics by cohort
| Measure |
Ketamine
n=21 Participants
Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.
ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
|
|---|---|
|
Age, Continuous
|
6.44 years
STANDARD_DEVIATION 4.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.Population: Children up to 18 years of age children with pre-existing congenital heart disease
pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model.
Outcome measures
| Measure |
Single Group Assignment
n=21 Participants
|
|---|---|
|
Total Clearance and Intercompartmental Clearance
Total Clearance
|
60.0 L/h/70kg
Interval 51.4 to 72.0
|
|
Total Clearance and Intercompartmental Clearance
Intercompartmental Clearance
|
70.8 L/h/70kg
Interval 49.7 to 106.0
|
PRIMARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.Population: Children up to 18 years of age children with pre-existing congenital heart disease
pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Central and Peripheral Volume of Distribution were analyzed using Bootstrap model.
Outcome measures
| Measure |
Single Group Assignment
n=21 Participants
|
|---|---|
|
Central and Peripheral Volume of Distribution
Central Volume of Distribution
|
57.6 L/70kg
Interval 45.0 to 82.6
|
|
Central and Peripheral Volume of Distribution
Peripheral Volume of Distribution
|
149 L/70kg
Interval 114.0 to 206.0
|
PRIMARY outcome
Timeframe: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.Population: Children up to 18 years of age children with pre-existing congenital heart disease
pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Residual Error was analyzed using Bootstrap model.
Outcome measures
| Measure |
Single Group Assignment
n=21 Participants
|
|---|---|
|
Residual Error
|
16.1 proportional %
Interval 13.4 to 18.7
|
Adverse Events
Single Group Assignment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place