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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Drug: Ketamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics of Ketamine in Infants and Children |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Term infants (38 weeks gestation)and infants and children up to age 18 years, but not including 18 years old.
- Patients who require procedures that necessitate at least 8 hours in the hospital and those being admitted after procedure will be eligible to participate.
- Patients who will receive ketamine as part of their standard anesthesia regimen.
Exclusion Criteria:Preterm neonates
- Liver Disease
- Kidney disease
- Heart failure
- Sepsis
- Patients receiving anticonvulsants or barbiturates
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100138
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Chandra Ramamoorthy | Stanford University |
More Information
No publications provided
| Responsible Party: | Chandra Ramamoorthy, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01100138 History of Changes |
| Other Study ID Numbers: | SU-04092008-1095, 3384 |
| Study First Received: | April 7, 2009 |
| Last Updated: | July 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013