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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01197417
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : September 7, 2015
Last Update Posted : January 27, 2016
Pediatric Emergency Care Applied Research Network
Information provided by (Responsible Party):
Medical College of Wisconsin

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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Intravenous Magnesium Sulfate Drug: Normal Saline Placebo Phase 2 Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Study Start Date : December 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Magnesium group
Intravenous Magnesium Sulfate
Drug: Intravenous Magnesium Sulfate
40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Placebo Comparator: Placebo group
Normal Saline placebo
Drug: Normal Saline Placebo
(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Primary Outcome Measures :
  1. Hospital Length of Stay (Hours) [ Time Frame: From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment ]

Secondary Outcome Measures :
  1. Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization [ Time Frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment ]
  2. Hypotension Associated With Infusion [ Time Frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
    For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.

  3. Warm Sensation Associated With Study Drug Infusion [ Time Frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ]
    Patient spontaneously reported feelings of warmth during any study drug infusion.

  4. Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge) ]
  5. Development of Acute Chest Syndrome (ACS) [ Time Frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment ]
  6. Hospital Length of Stay [ Time Frame: Start of first study drug infusion to actual hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01197417

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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia Research Institute
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Pediatric Emergency Care Applied Research Network
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Principal Investigator: David Brousseau, MD, MS Medical College of Wisconsin
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical College of Wisconsin Identifier: NCT01197417    
Other Study ID Numbers: PECARN 025
First Posted: September 9, 2010    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: January 27, 2016
Last Verified: December 2015
Keywords provided by Medical College of Wisconsin:
Sickle Cell Disease
Magnesium Sulfate
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents