Sickle Cell Disease Clinical Trial
Official title:
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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