Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT00598195
Eligibility Criteria:
Inclusion Criteria:
* ≤ 6 years of age
* cardiac surgical procedure
* Indwelling arterial line or central venous line for blood sampling
Exclusion Criteria:
* patients with known hepatic dysfunction(\>3 times normal AST \& ALT)
* clinically significant alteration (as determined by the investigator) hemoglobin or hematocrit
* patients receiving medications known to be potent inhibitors or inducers of CYP3A4 and CYP2C19
* patients with significant malnutrition (\< 1%tile for age-adjusted weight)
* patients enrolled in other studies that require frequent blood sampling during and after cardiac surgery
* any contraindication for ketamine administration
* ketamine administration within the previous 24 hours
* Patients with known history of pulmonary hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
6 Years
Study:
NCT00598195
Study Brief:
Protocol Section:
NCT00598195