Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally
Status:
Completed
Trial end date:
2016-10-18
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Children's Healthcare of Atlanta
Collaborator:
Atlanta Clinical and Translational Science Institute