Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Study Population:
Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with
CPB.
The use of methadone to provide analgesia may be increasing due to advantages compared to
other commonly used opioid analgesic drugs. While efficacy of methadone has been reported in
adults, there is a paucity of information in neonates and infants. In the latter population,
fentanyl and morphine are most commonly used for opioid analgesia following major surgery,
while methadone is frequently used for weaning of opioid dependent and tolerant patients, in
spite of the paucity of knowledge of methadone pharmacology in this population. There are
several clinical problems associated with fentanyl and morphine, and methadone may offer
superior efficacy with fewer side effects than these agents. We propose to study the
pharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in the
intensive care unit following cardiac surgery.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Stanford University
Collaborators:
Oregon Health and Science University University of Colorado, Denver