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NCT00286052 · ClinicalTrials.gov registry record · Phase 3
Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
NCT00286052 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 128 participants.
The verdict
NCT00286052, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
Study 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 patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may
Interventions
- DRUG Low Dose Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2002-12 |
| Est. Completion | 2004-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00286052
The ClinicalTrials.gov registry entry for NCT00286052 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low Dose Naloxone is the first listed.
NCT00286052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00286052 about?
NCT00286052 is a clinical study titled "Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients". 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 patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) prov...
What is the current status of trial NCT00286052?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2002-12. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00286052?
The interventions under investigation include: Low Dose Naloxone (DRUG).
Who is sponsoring clinical trial NCT00286052?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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