PECARN Network
revised
9/28/15

 

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (Magnesium in Crisis [MAGIC])


Study Type: Interventional (IND)
Study Period: December 2010 - March 2014
Enrollment: 208
Consent: Yes

PURPOSE:

This was a multi-center, randomized, double-blind, placebo controlled trial of participants aged 4-21 years old with sickle cell anemia (defined by Hb SS or Hb Sß0 thalassemia disease) who presented to the emergency department with a sickle cell vasoocclusive crisis. The purpose of this study was to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis when added to standard care in children with sickle cell disease (SCD) who are hospitalized for an acute pain crisis. Patients were randomized to receive either the study drug or placebo every eight hours for a total of six doses, or until discharge (whichever occurred first). Patients were followed up by phone one week after discharge to assess rehospitalization rates and returned to the sickle cell clinic for follow up one to three months after discharge. The hypotheses of this study were as follows:

  1. intravenous magnesium is an effective agent for the treatment of patients hospitalized for an acute sickle cell pain episode;
  2. the addition of intravenous magnesium sulfate to standard inpatient therapy is safe for patients hospitalized with an acute sickle cell pain episode;
  3. the beneficial effect of intravenous magnesium is, in part, due to increased endothelial cell nitric oxide production and/or improvement of endothelial dysfunction.
  4. children receiving magnesium therapy will have better health-related quality of life (HRQL) at completion of treatment and better short term outcomes after hospital discharge than those receiving placebo therapy;
  5. the PedsQL Sickle Cell Disease module will be responsive to temporal changes in health status of the child

Patient enrollment took place between December 2010-March 2014 with last follow up procedures completed in May 2014. This project was co-funded by NICHD and NHLBI.

 

Study Documents: