MAST - Magnesium for Sickle Cell Acute Crisis in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.

Detailed Description
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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.

Official Title
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MAST - Magnesium for Sickle Cell Acute Crisis in Children

Conditions
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Anemia, Sickle Cell

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known sickle cell disease Previous painful crisis resulting in an Emergency Department(ED) visit Current visit with a chief complaint of pain Age 4 years - 18 years Staff ED decides to admit to the hospital Staff ED decides to start an intravenous line Exclusion Criteria: Fever (>38.5C) during the 24 hours prior to visit at triage Patients transfused within 90 days of study entry Patients with known renal disease Patients with known heart block or myocardial damage Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours Patients or parents unable to communicate in English Known pregnancy Known allergy to Magnesium Admission to the ICU Enrolment to the study in the last 30 days

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Magnesium Sulfate<br>* Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.<br>|
| Placebo Comparator: 2<br> | Drug: Normal Saline<br>* Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the hospital |  | Time frame determined by outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction mean daily pain score during an admission for sickle cell pain crisis |  | Length of hospital stay | 
| Adverse events during admission |  | Length of hospital stay | 
| Cumulative Narcotic drug required to manage the crises during admission |  | Length of hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Sickle Cell, Magnesium Sulfate, pediatric