Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally



Status:Completed
Conditions:Chronic Pain, Anemia
Therapuetic Areas:Hematology, Musculoskeletal
Healthy:No
Age Range:6 - 19
Updated:2/22/2018
Start Date:May 26, 2010
End Date:October 18, 2016

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Choosing Opioid Management for Pain and Analyzing ACS Rates Equally

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.


Inclusion Criteria:

- Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute
painful episodes

- 6 years old and < 19 years old

- Normal baseline chest radiograph

- Normal renal and hepatic function within the previous 12 months

Exclusion Criteria:

- Previous patient participation in this clinical trial

- Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest
radiograph on admission

- Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or
off treatment

- Any patient with documented allergy to either study drug

- Any patient with known evidence of an underlying disease that would interfere with
evaluation of a therapeutic response such as:

- Hepatic dysfunction (3x ALT),

- Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),

- Pulmonary Hypertension (TRJ >3.0),

- Cardiac dysfunction.

- Any patient with symptoms of an acute stroke.

- Any patient known or suspected to be pregnant.

- Any patient with priapism

- The patient or guardian who will not give consent or assent to be randomized.
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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mi
from
Atlanta, GA
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