Status:
COMPLETED
Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Opioid Tolerance
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU...
Detailed Description
Objective: To determine if Naloxone administration to pediatric ICU patients on Fentanyl infusions require less Fentanyl compared to control patients. Background: During recent years there has been...
Eligibility Criteria
Inclusion
- Children age one (1) day to eighteen (18) years, requiring admission to the Pediatric ICU, requiring continuous infusion of Fentanyl analgesic anticipated to last greater than 4 days will be eligible for enrollment. Patients from both genders, all races and ethnic backgrounds will be eligible. Patients meeting the above criteria will be eligible regardless of nutritional status, performance status or recovery from prior medical treatment. They will not be excluded if they require simultaneous infusions of sedation with Midazolam. 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.
- History of significant or preexisting cardiovascular disease, they are receiving pro-arrhythmia medications, such as class I, II, III or IV antiarrhythmic agents.
- Patients who are allergic to opioids or opioid antagonists.
- Patients with documented chromosomal abnormality impairing perception of pain/discomfort.
- Unable to obtain parental or legal guardian's informed consent
- Concurrent admission to another study.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00286052
Start Date
December 1 2002
End Date
August 1 2004
Last Update
February 2 2006
Active Locations (1)
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1
Unversity of Texas Southwestern, Children's Medical Center, Dallas
Dallas, Texas, United States, 75235