MAST - Magnesium for Sickle Cell Acute Crisis in Children
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|ClinicalTrials.gov Identifier: NCT00313963|
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anemia, Sickle Cell||Drug: Magnesium Sulfate Drug: Normal Saline||Phase 3|
Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.
In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||MAST - Magnesium for Sickle Cell Acute Crisis in Children|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||July 2013|
Drug: Magnesium Sulfate
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
|Placebo Comparator: 2||
Drug: Normal Saline
Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
- Length of stay in the hospital [ Time Frame: Time frame determined by outcome ]
- Reduction mean daily pain score during an admission for sickle cell pain crisis [ Time Frame: Length of hospital stay ]
- Adverse events during admission [ Time Frame: Length of hospital stay ]
- Cumulative Narcotic drug required to manage the crises during admission [ Time Frame: Length of hospital stay ]
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 ClinicalTrials.gov identifier (NCT number): NCT00313963
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jeremy Friedman, MD||The Hospital for Sick Children, Toronto Canada|