Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Patient-Specific Protocol; Weight-based Protocol; Morphine; Hydromorphone
Intervention description: Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours.; Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.; 4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.; 1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to compare two different ways to give opioid pain
      medicine to treat sickle cell disease pain that is bad enough to go to the emergency
      department for treatment. One way uses your weight to decide how much pain medicine to give
      you while in the emergency department. This is called weight based treatment. The other way
      uses how much pain medicine you take at home and how much medicine you needed during past
      emergency department visits to decide how much medicine to give you. This is called patient
      specific treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult (18 years or older);

          -  Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell
             anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and
             SB-(sickle Beta zero thalassemia)

        Exclusion Criteria:

          -  determined to not benefit from opioids and therefore won't receive opioids in any
             future Emergency Department visit.