Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

It is well known that children with sickle cell disease are at risk for acute pain crises.
The usual treatment for these pain crises, intravenous fluids and pain medicines such as
morphine, has changed little over the past three decades. In a pilot study, the addition of
intravenous magnesium to standard therapy decreased length of stay; however, this study was
not randomized, not blinded, not placebo-controlled, and not adequately powered to assess
safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about
208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium
sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will
return for a routine clinic visit up to 3 months after discharge for a baseline assessment.
Patients will also complete health-related quality of life measures at 4 timepoints
throughout the study.

Inclusion Criteria:

- age 4-21 years, inclusive

- Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)

- failed intravenous opioid pain management in the emergency department prior to the
decision to admit the patient

- admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

- patient received more than 12 hours of intravenous pain medication prior to
enrollment

- previous enrollment in this study (only one admission per child is eligible)

- history of allergy/intolerance to both intravenous morphine and hydromorphone

- known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)

- patient with greater than 10 admissions for pain crisis in the past year

- patient maintained on daily opioids or chronic transfusions for chronic sickle cell
pain

- transfusion within the previous two months

- known kidney or liver failure (elevation of liver function tests does not warrant
exclusion)

- known pulmonary hypertension

- pregnancy

- diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic
instability or sepsis

- current oral magnesium supplementation or current enrollment in another therapeutic
study protocol

- previously diagnosed clinical stroke

- current or planned use of neuromuscular blocker, nifedipine, ritodrine, or
terbutaline

- allergy to magnesium sulfate

- discharge from an inpatient unit within 72 hours of arrival in the emergency
department for the current pain crisis