Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004696
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Morphine in Postoperative Infants to Allow Normal Ventilation
Sponsor:
Seattle Childrens Hospital
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHMC-S-IRB-148-9706 | None | None | None |
| CHMC-S-FDR001015 | None | None | None |
| CHMC-S-IRB-022-9801 | None | None | None |