Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.

Key facts

Study ID

NCT01197417

Run by

Medical College of Wisconsin

People needed

208

Starts

2010-12-01

Expected to finish

2014-03-01

Last updated by the study team

2016-01-27

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia Research Institute — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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