MAST - Magnesium for Sickle Cell Acute Crisis in Children

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Anemia, Sickle Cell

Treatments: Drug: Magnesium Sulfate; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00313963

1000008367

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Magnesium Sulfate

2

Placebo Comparator group

Treatment:

Drug: Normal Saline