C.Surgical Procedure; CardiacNCT00598195
Ketamine Pharmacokinetics in Children Having Heart Surgery
A study testing Ketamine in people with C.Surgical Procedure; Cardiac, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 6 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤ 6 years of age
- cardiac surgical procedure
- Indwelling arterial line or central venous line for blood sampling
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Ketamine Pharmacokinetics in Children Undergoing Cardiac Surgery
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.
Read the detailed description
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.
- Conditions
- C.Surgical Procedure; Cardiac
- Being tested
- Ketamine
- Keywords
- Ketamine, Phamacokinetics, Cardiopulmonary bypass (CPB), ketamine/norketamine pharmacokinetic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Pharmacokinetics | No intervention | The pharmacokinetic action of Ketamine used in Children having heart surgery. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure how long ketamine remains in blood after a single dose of ketamine is given (venous) to children undergoing cardiac surgery on cardiopulmonary bypass (CPB)compared to levels of children undergoing cardiac surgery without CPB.
Measured: Length of time ketamine remains in the blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnan T Bhutta, M.D., Principal investigator, Arkansas Children's Hospital and University of Arkansas for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598195
- Sponsor's protocol ID
- 57839
- Status last verified
- Feb 2013
- First submitted
- 26 Dec 2007
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Pharmacokinetics in Children Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00598195
- Acronym / sponsor ID
- 57839
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- Ketamine, Phamacokinetics, Cardiopulmonary bypass (CPB), ketamine/norketamine pharmacokinetic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine Pharmacokinetics | No intervention | Drug: KetamineThe pharmacokinetic action of Ketamine used in Children having heart surgery. |
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≤ 6 years of age
- cardiac surgical procedure
- Indwelling arterial line or central venous line for blood sampling
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketaminesubject 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. | Drug | Ketamine Pharmacokinetics |
Primary outcome
To measure how long ketamine remains in blood after a single dose of ketamine is given (venous) to children undergoing cardiac surgery on cardiopulmonary bypass (CPB)compared to levels of children undergoing cardiac surgery without CPB.
Time frame: Length of time ketamine remains in the blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan T Bhutta, M.D. principal investigator
Arkansas Children's Hospital and University of Arkansas for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with C.Surgical Procedure; Cardiac, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure how long ketamine remains in blood after a single dose of ketamine is given (venous) to children undergoing cardiac surgery on cardiopulmonary bypass (CPB)compared to levels of children undergoing cardiac surgery without CPB. (time frame: Length of time ketamine remains in the blood). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.