Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally
Condition: Pain; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Morphine; Nubain
Intervention description: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).; Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 6 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: pain; sickle cell; nubain; morphine; acute chest; side effects

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.
    

Eligibility criteria:

        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.