Pain Clinical Trial
OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine
postoperatively as intermittent intravenous bolus doses or as a continuous intravenous
infusion targeted to reach a steady-state concentration.
II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and
analgesia (infant pain score) between the two treatment groups of infants.
III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from
assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.
PROTOCOL OUTLINE: This is a two part study. Infants are stratified by age (1-30 days vs
31-180 days vs 181-365 days) and by type of surgery. Infants are randomly assigned to one of
two treatment arms.
In part I, following major thoracic, abdominal, or cardiac surgery, infants are randomized
to receive either continuous IV morphine infusions (arm I) or to receive morphine by single
IV bolus doses every 2-3 hours (arm II).
In part II, cyanotic and acyanotic infants following thoracotomy receive morphine by 2
loading doses over 15 minutes and then by continuous IV infusion.
Patients are followed for at least 2 days.
Completion date provided represents the completion date of the grant per OOPD records
;
Allocation: Randomized
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