MAST - Magnesium for Sickle Cell Acute Crisis in Children
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 13, 2013
August 1, 2013
2.3 years
April 10, 2006
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of stay in the hospital
Time frame determined by outcome
Secondary Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
Goldman RD, Mounstephen W, Kirby-Allen M, Friedman JN. Intravenous magnesium sulfate for vaso-occlusive episodes in sickle cell disease. Pediatrics. 2013 Dec;132(6):e1634-41. doi: 10.1542/peds.2013-2065. Epub 2013 Nov 25.
PMID: 24276838DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Friedman, MD
The Hospital for Sick Children, Toronto Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
April 1, 2006
Primary Completion
August 1, 2008
Study Completion
July 1, 2013
Last Updated
August 13, 2013
Record last verified: 2013-08