Study of a Drug Called "Ketamine" and How Much is in the Bloodstream of Infants and Children Who Have Undergone Surgery. Ketamine is a standard-of- Care Medication Used in the Intensive Care Unit at Stanford for Sedation and Anesthesia.
This study is ongoing, but not recruiting participants.
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01100138
First received: April 7, 2009
Last updated: July 27, 2011
Last verified: July 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2009 | ||||
| Last Updated Date | July 27, 2011 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetics [ Time Frame: 8 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01100138 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of a Drug Called "Ketamine" and How Much is in the Bloodstream of Infants and Children Who Have Undergone Surgery. Ketamine is a standard-of- Care Medication Used in the Intensive Care Unit at Stanford for Sedation and Anesthesia. | ||||
| Official Title ICMJE | Pharmacokinetics of Ketamine in Infants and Children | ||||
| Brief Summary | Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: Ketamine
2mg/kg intravenous dose of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). This is a one-time dose.
Other Name: Ketalar, Ketaset, Ketanest |
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| Study Arm (s) | Experimental: Ketamine
Open label study of the pharmacokinetics of ketamine used during surgery. The dose will be standardized for all subjects at 2 mg/kg (IV) over 5 minutes, once the patient's surgery is underway.
Intervention: Drug: Ketamine |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:Preterm neonates
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| Gender | Both | ||||
| Ages | up to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01100138 | ||||
| Other Study ID Numbers ICMJE | SU-04092008-1095, 3384 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Chandra Ramamoorthy, Stanford University School of Medicine | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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