Status:
TERMINATED
Pharmacokinetics of Low Dose Ketamine Infusion
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Sedation
Opioid Tolerance
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief Summary
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 P...
Detailed Description
Background: There has been an increasing awareness of the need for adequate sedation and analgesia in critically ill pediatric patients. The choices of treatment for pain are numerous, but in the Ped...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00618397
Start Date
June 1 2006
End Date
June 1 2015
Last Update
October 26 2016
Active Locations (1)
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1
Children's Medical Center Dallas, University of Texas Southwestern
Dallas, Texas, United States, 75235