Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients
Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
Participant gender:
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
cause shorter Intensive Care Unit stays.