Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 term outcomes of children treated with intravenous magnesium during an acute pain crisis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborator: Pediatric Emergency Care Applied Research Network
• Treatments: Magnesium Sulfate

Criteria

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