MAST - Magnesium for Sickle Cell Acute Crisis in Children

MAST - Magnesium for Sickle Cell Acute Crisis in Children

Sponsors

Lead Sponsor: The Hospital for Sick Children

Collaborator: The Physicians' Services Incorporated Foundation

Source 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.

Overall Status Completed
Start Date April 2006
Completion Date July 2013
Primary Completion Date August 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Length of stay in the hospital Time frame determined by outcome
Secondary Outcome
Measure Time Frame
Reduction mean daily pain score during an admission for sickle cell pain crisis Length of hospital stay
Adverse events during admission Length of hospital stay
Cumulative Narcotic drug required to manage the crises during admission Length of hospital stay
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Magnesium Sulfate

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

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: Normal Saline

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

Arm Group Label: 2

Eligibility

Criteria:

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

Gender: All

Minimum Age: 4 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeremy Friedman, MD Principal Investigator The Hospital for Sick Children, Toronto Canada
Location
Facility: The Hospital for Sick Children
Location Countries

Canada

Verification Date

August 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov