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MAST - Magnesium for Sickle Cell Acute Crisis in Children

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ClinicalTrials.gov Identifier: NCT00313963
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : August 13, 2013
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: Magnesium Sulfate Drug: Normal Saline Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: MAST - Magnesium for Sickle Cell Acute Crisis in Children
Study Start Date : April 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: 1 Drug: Magnesium Sulfate
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.

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




Primary Outcome Measures :
  1. Length of stay in the hospital [ Time Frame: Time frame determined by outcome ]

Secondary Outcome Measures :
  1. Reduction mean daily pain score during an admission for sickle cell pain crisis [ Time Frame: Length of hospital stay ]
  2. Adverse events during admission [ Time Frame: Length of hospital stay ]
  3. Cumulative Narcotic drug required to manage the crises during admission [ Time Frame: Length of hospital stay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313963


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Jeremy Friedman, MD The Hospital for Sick Children, Toronto Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00313963     History of Changes
Other Study ID Numbers: 1000008367
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by The Hospital for Sick Children:
Anemia, Sickle Cell
Magnesium Sulfate
pediatric

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents