Steroid Treatment for Sickle Cell Pain Crisis
Condition: Sickle Cell Disease; Vaso-occlusive Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Steroid arm; Placebo
Intervention description: Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily; Patients received normal saline in lieu of intravenously-administered methylprednisolone and placebo pills equal in number to the steroid pills received in the steroid arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: Sickle cell disease; vaso-occlusive crisis; steroid treatment

Summary:

      The painful episode is the most common problem experienced by children with sickle cell
      disease. Although various treatments are available during painful episodes, the medication
      most commonly given for pain is a pain medication such as morphine. Fluids are also used.
      Even with these treatments, many children still have severe pain that is difficult to
      control. In addition to pain medications, there are other medications that may be useful.
      Methylprednisolone (solumedrol) and prednisone are a group of medications called steroids
      that may be helpful for painful episodes. These medications are known to lower the amount of
      inflammation (this means swelling, tenderness, and soreness) in the body. Because this
      medication may help with your pain, you are being asked to be a part of this study. These
      types of medications are used in other illnesses such as asthma, especially during times when
      the illness has gotten worse.

      The main purpose of this study is to see if the methylprednisolone and prednisone will lower
      the amount of pain and the length of hospital stay.

      In addition to the pain medication you will normally receive, you will be assigned to one of
      2 groups: 1) the experimental group with the active form of the medicine, or 2) a comparison
      group without the active form of the medicine. In either group, you will still receive all of
      the treatments you would normally receive for a painful episode, including pain medicines and
      fluids. You and your doctors will not know what group you will be assigned.

      If you decide to be a part of the study the following will happen:

      For the first 5 days, you will be asked to: 1) describe your current pain (0=no pain to 10=a
      lot of pain), worst pain (0=no pain to 10=a lot of pain), least pain (0=no pain to 10=a lot
      of pain), and the amount of pain relief (0=no relief to 10=complete relief); 2) describe any
      signs or symptoms you feel, including filling out a pain scale form each day; 3) and take the
      medicines for 5 days, either at home or when in the hospital. Thirty days after the study, a
      study researcher will call and will ask questions about your pain, any painful episodes, and
      any medications you had. If you are discharged home sooner than 5 days after the start of the
      study, research staff will call you to ask you these questions, remind you to fill out your
      pain forms, and remind you to take your medicine. If you are discharged home, you will be
      given pain scales to fill out each day at home.
    

Eligibility criteria:

        Inclusion Criteria:

        Sickle cell and acute pain Age 8 and up English or Spanish-speaking

        Exclusion Criteria:

        Fever greater than 101 Acute chest syndrome or pneumonia Other SS complications
        (sequestration, aplastic crisis) Other explanation for pain (chronic, AVN, surgical)
        History of GI bleeding, HTN, or hyperglycemia/DM