Overview

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