NCT00004696

Study of Morphine in Postoperative Infants to Allow Normal Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Infant, Newborn, Diseases
• Pain

Interventions

Type	Name	Description
DRUG	morphine

Timeline

• Start date: 1994-08-01
• Completion: 1998-07-01
• First posted: 2000-02-25
• Last updated: 2015-03-25