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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Children's Hospital and Regional Medical Center, Seattle |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004696 |
Purpose
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.
| Condition | Intervention |
|
Infant, Newborn, Diseases Pain |
Drug: morphine |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 1994 |
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.
Eligibility
| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Part I patients:
Part II patients:
--Patient Characteristics--
Other:
Contacts and Locations| FDA Office of Orphan Products Development |
| Children's Hospital and Regional Medical Center, Seattle |
| Study Chair: | Anne M. Lynn | Children's Hospital and Regional Medical Center, Seattle |
More Information
| Study ID Numbers: | 199/13359, CHMC-S-FDR001015, CHMC-S-IRB-022-9801, CHMC-S-IRB-148-9706 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004696 |
| Health Authority: | United States: Federal Government |
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