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Sponsored by: |
Arkansas Children's Hospital Research Institute |
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Information provided by: | Arkansas Children's Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00598195 |
What are the pharmacokinetics of ketamine in infants and children requiring ketamine for induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass). Specific Aim 2: To describe the disposition of ketamine's primary active metabolite, norketamine,following a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB. Specific Aim 3: To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time.
Condition | Intervention |
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Cardiac Surgery |
Drug: Ketamine |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment |
Official Title: | Ketamine Pharmacokinetics in Children Undergoing Cardiac Surgery |
Estimated Enrollment: | 28 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
subject will then receive an intravenous bolus dose of ketamine 2 mg/kg as a rapid intravenous bolus, over less than two minutes just prior to CPB. In the non-CPB patients, ketamine will be administered just prior to the skin incision. All doses will be rounded to the nearest tenth of a milligram.
Timed blood samples will be collected at standardized times after the completion of the ketamine infusion and samples will be obtained from an indwelling arterial line. Each blood sample for pharmacokinetic analysis will be 1 mL.
The role of ketamine in pediatric anesthesia is well established. It is one of the most commonly used agents for conscious sedation in pediatrics. Its widespread use stems for its abrupt onset of action and brief duration of sedation. There is limited ketamine pharmacokinetic data in children and none to our knowledge in infants and young children who will be given an intravenous bolus dose before a surgical procedure that includes cardiopulmonary bypass. Ketamine is marketed as a racemic mixture (50:50 mixture of S- and R-ketamine enantiomers).
Ketamine undergoes N-demethylation (CYP3B6, 2C9, and 3A4) to its primary active metabolite,norketamine, with minor inactive metabolites, dehydroxynorketamine, generated secondary to direct oxidation. Ketamine exhibits a high intrinsic clearance with hepatic clearance dependent on hepatic blood flow under normal circumstances. One inherent disadvantage associated with the use of cardiopulmonary bypass (CPB) is the potential for organ dysfunction post-operatively. We propose an open-label controlled study describing the disposition of ketamine in 28 infants and children who will be undergoing cardiac surgery with (n=16) and without (n=12) CPB. We anticipate that cardiopulmonary bypass alters the pharmacokinetics of ketamine.
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Arkansas Children's Hospital | Recruiting |
Little Rock, Arkansas, United States, 72202 | |
Contact: Adnan T Bhutta, M.D. 501-364-4980 bhuttaadnant@uams.edu | |
Principal Investigator: Adnan T Bhutta, M.D. |
Principal Investigator: | Adnan T Bhutta, M.D. | Arkansas Children's Hospital and University of Arkansas for Medical Sciences |
Responsible Party: | Arkansas Children's Hospital ( Adnan Bhutta, Prinicpal Investigator ) |
Study ID Numbers: | 57839 |
Study First Received: | December 26, 2007 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00598195 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ketamine Phamacokinetics Cardiopulmonary bypass (CPB) |
Determining pharmacokinetic parameters of a single dose of ketamine in infants and children undergoing cardiac surgery with and without CPB. Describing the disposition norketamine following a single dose of ketamine in infants and children undergoing cardiac surgery with and without CPB. To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time. |
Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Anesthetics, General Ketamine |
Central Nervous System Depressants Anesthetics Peripheral Nervous System Agents Analgesics Anesthetics, Dissociative |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative Pharmacologic Actions |
Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |