MAST - Magnesium for Sickle Cell Acute Crisis in Children

The Hospital for Sick Children120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Anemia, Sickle Cell

Interventions

Magnesium SulfateDRUG

Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.

Normal SalineDRUG

Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Length of stay in the hospital

Time frame: Time frame determined by outcome

Secondary Outcomes

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

Data from ClinicalTrials.gov

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