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Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Trial ID: NCT01094522
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.
A Randomized, Double-blind, Controlled, Multi-site Study of the Pharmacokinetics and Pharmacodynamics of Methadone vs. Morphine During Mechanical Ventilation Following Cardiac Surgery in Neonates, Infants and Children
Neonates, infants and children from birth through 5 years of age undergoing mechanical
ventilation following cardiac surgery for congenital heart disease. Congenital heart
lesions include "two ventricle repairs", including tetralogy of Fallot, transposition of
the great arteries, "unobstructed" total anomalous pulmonary venous return, truncus
arteriosus, atrioventricular canal defect and ventricular septal defect.
Subjects will be excluded from the study because of prematurity (gestational age < 37
weeks), weight < 3.0 kg, severe hepatic dysfunction (elevation of conjugated bilirubin > 2,
AST/ALT > 200 IU/L), significant renal dysfunction (serum Cr > 1.5 mg/dL), participation
within 30 days of study entry or within 5 times the half-life, whichever is longer, in
another investigational drug study, or previous participation in this study. Patients will
be excluded if they have received opioids for more than 12 hours of the 48-hour period
prior to surgery. In addition, patients will be excluded if they have a history of other
clinically significant medical problems, which, in the opinion of the investigator, would
interfere with study participation.
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