MAST - Magnesium for Sickle Cell Acute Crisis in Children

Anemia, Sickle Cell Clinical Trial

Official title:

MAST - Magnesium for Sickle Cell Acute Crisis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313963
• Other study ID #: 1000008367
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: August 9, 2013
• Start date: April 2006
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in the hospital		Time frame determined by outcome	No
Secondary	Reduction mean daily pain score during an admission for sickle cell pain crisis		Length of hospital stay	No
Secondary	Adverse events during admission		Length of hospital stay	Yes
Secondary	Cumulative Narcotic drug required to manage the crises during admission		Length of hospital stay	No