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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00618397 |
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Date of registration:
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06/02/2008 |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Low Dose Ketamine Infusion
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Scientific title:
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Phase I Trial to Determine Steady State Pharmacokinetics and Sedative Effects of Low Dose Ketamine Infusion |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00618397 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Cindy Darnell, MD |
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Address:
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Telephone:
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214-456-7968 |
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Email:
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cindy.darnell@childrens.com |
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Affiliation:
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Name:
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Cindy Darnell, MD |
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Address:
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Telephone:
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214-456-7968 |
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Email:
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cindy.darnell@childrens.com |
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Affiliation:
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Name:
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Cindy Darnell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients will be eligible if they meet the following criteria:
- Children age one three (3) years to eighteen (18) years, requiring admission to the
Pediatric ICU, who require intubation for respiratory failure and continuous infusion
fentanyl.
- Patients of both genders, all races and ethnic backgrounds will be eligible.
- Patients will need to have AST and ALT evaluated within the two weeks prior to
enrollment, with the result being within two times the normal range. Patients who
have not had AST and ALT evaluated within two weeks will have to be evaluated prior
to enrollment. Serum will be evaluated for AST and ALT when convenient to other lab
testing prior to enrollment.
- Patients meeting the above criteria will be eligible regardless of nutritional
status, performance status or recovery from prior medical treatment.
- Patients will not be excluded if they require simultaneous infusions of sedation with
benzodiazepine.
- Enrollment will require parental consent.
Exclusion Criteria:
- Patients will not be eligible if they meet any of the following criteria:
- Patients who are currently on oral analgesia or sedation
- Patients who have a prior history of drug or alcohol dependence/abuse.
- Patients who are allergic to opioids.
- Patients who are allergic to ketamine or any NMDA antagonist. Patients in whom
significant elevation of blood pressure would constitute a serious hazard
- Patients with documented or clinical concern for elevated intracranial pressure.
- Patients with known liver dysfunction as evidenced by AST and ALT two times the
normal limit within the past two weeks.
- Patients who are being medically paralyzed as part of their current treatment.
- Patients with any underlying neurologic condition, or impairment, which would
interfere with their perception of, or response to, pain or discomfort.
Age minimum:
3 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opioid Tolerance
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Sedation
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Intervention(s)
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Drug: Ketamine
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Primary Outcome(s)
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To establish if continuous infusions of ketamine in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr cause serum levels > 1 mcg/ml.
[Time Frame: 6 and 12 hours after begining infusion]
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Secondary Outcome(s)
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To define the pharmacokinetics of continuous infusion ketamine in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr.
[Time Frame: 6 and 12 hours after infusion]
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Secondary ID(s)
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042006035
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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