Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01380197
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2011-06-22
Brief Title:
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome ACS Rates Equally
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Choosing Opioid Management for Pain and Analyzing ACS Rates Equally
Status:
COMPLETED
Status Verified Date:
2018-01
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:
COMPARE
Brief Summary:
The pathophysiology of sickle cell disease SCD manifestations are complex with interactions of intracellular hemoglobin membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes VOC These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen inflexible erythrocytes Painful episodes are the most common cause of hospitalization morbidity and impairment for SCD patients There is no therapy that completely prevents or directly aborts painful events for all patients Consequently treatment for acute VOC is primarily supportive using hydration and medicinal pain control Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects
The primary hypothesis to be tested in this double blind randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome The investigators also expect subjects will report fewer side effects from respiratory depression abdominal distention from reduced peristalsis reduced histamine release causing pruritis and still be provided adequate pain control Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia PCA is safe and effective in controlling pain requiring less total opiates consumption while decreasing length of hospitalization
The primary hypothesis to be tested in this double blind randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome The investigators also expect subjects will report fewer side effects from respiratory depression abdominal distention from reduced peristalsis reduced histamine release causing pruritis and still be provided adequate pain control Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia PCA is safe and effective in controlling pain requiring less total opiates consumption while decreasing length of hospitalization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None