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| Sponsor: | Arkansas Children's Hospital Research Institute |
|---|---|
| Information provided by (Responsible Party): | Arkansas Children's Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00598195 |
Purpose
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 |
|---|---|
|
Cardiac Surgery |
Drug: Ketamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Ketamine Pharmacokinetics in Children Undergoing Cardiac Surgery |
| Enrollment: | 18 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| Principal Investigator: | Adnan T Bhutta, M.D. | Arkansas Children's Hospital and University of Arkansas for Medical Sciences |
More Information
| Responsible Party: | Arkansas Children's Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00598195 History of Changes |
| Other Study ID Numbers: | 57839 |
| Study First Received: | December 26, 2007 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Ketamine Phamacokinetics Cardiopulmonary bypass (CPB) ketamine/norketamine pharmacokinetic parameters |
|
Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |