MAST - Magnesium for Sickle Cell Acute Crisis in Children

Phase 3

Completed

• Conditions: Anemia, Sickle Cell
• Interventions: Drug: Normal Saline; Drug: Magnesium Sulfate

• Registration Number: NCT00313963
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-12
• Primary Completion: 2008-08
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Normal Saline	-
1	Magnesium Sulfate	-

Primary Outcome Measures

Name	Time	Method
Length of stay in the hospital	Time frame determined by outcome

Secondary Outcome Measures

Name	Time	Method
Adverse events during admission	Length of hospital stay
Reduction mean daily pain score during an admission for sickle cell pain crisis	Length of hospital stay
Cumulative Narcotic drug required to manage the crises during admission	Length of hospital stay

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada