Status:
COMPLETED
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Pediatric Emergency Care Applied Research Network
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
4-21 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ter...
Detailed Description
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 change...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01197417
Start Date
December 1 2010
End Date
March 1 2014
Last Update
January 27 2016
Active Locations (8)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205