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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00618397 |
Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain control. Opioid tolerance, the need to increase the dose of medication to achieve the same effect,is seen in PICU children who require opioid infusions. Animals and human studies have shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the development of opioid tolerance and that deactivation of this receptor can slow the development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in inhibiting the development of opioid tolerance has not been tested in children. We aim to determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require fentanyl infusions to treat pain and discomfort .
Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr.
Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for discomfort or pain control will be enrolled. Patients' age three to eighteen years will be enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a validated scale that measures distress in PICU patients. The COMFORT score will be continued for the twelve hours the patient receives the ketamine to test whether the ketamine adds to the level of sedation. Blood samples during and following the ketamine infusion will be taken to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the body.
To determine the effect of ketamine on tolerance it must be a ketamine dose that does not cause additional sedation. The goal of this study is to define a non-sedating dose of ketamine and define how it is used by the body. A non-sedating ketamine dose could be added to current sedation regimens allowing us to monitor the development of tolerance without the confusion of added sedation. The data obtained in this study will be used to design a study to further investigate the effect of ketamine on opioid tolerance.
Condition | Intervention | Phase |
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Sedation Opioid Tolerance |
Drug: Ketamine |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Phase I Trial to Determine Steady State Pharmacokinetics and Sedative Effects of Low Dose Ketamine Infusion |
Estimated Enrollment: | 15 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
Ketamine will be administered in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr to in PICU patients that meet eligibility criteria.
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Drug: Ketamine
Ketamine administered in doses of 0.01mg/kg/hr, 0.1mg/kg/hr and 0.5mg/kg/hr to PICU patients.
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Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: Cindy Darnell, MD | 214-456-7968 | cindy.darnell@childrens.com |
United States, Texas | |
Children's Medical Center Dallas, University of Texas Southwestern | Recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Cindy Darnell, MD 214-456-7968 cindy.darnell@childrens.com | |
Principal Investigator: Cindy Darnell, MD |
Principal Investigator: | Cindy Darnell, MD | University of Texas Southwestern |
Responsible Party: | University of Texas Southwestern ( Cindy Darnell, MD/ Assistant Professor Pediatrics ) |
Study ID Numbers: | 042006035 |
Study First Received: | February 6, 2008 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00618397 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ketamine pharmcokinetics sedation |
critical care opioid tolerance NMDA Antagonist |
Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Anesthetics, General Ketamine |
Central Nervous System Depressants Anesthetics Peripheral Nervous System Agents Analgesics Anesthetics, Dissociative |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative Pharmacologic Actions |
Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |