Latest1 information on COVID-19
©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01094522
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
Professor of Anesthesiology, Perioperative and Pain Medicine
Lawrence Crowley, M.D., Endowed Professor of Child Health
Inclusion Criteria:
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.
Exclusion Criteria:
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.
drug: Methadone
drug: Morphine
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Gregory Hammer
6507237835