NCT00313963

MAST - Magnesium for Sickle Cell Acute Crisis in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anemia, Sickle Cell

Interventions

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

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-08-01
• Completion: 2013-07-01
• First posted: 2006-04-12
• Last updated: 2013-08-13

Locations

1 site across 1 country: Canada