Clinical trial NCT00313963: MAST - Magnesium for Sickle Cell Acute Crisis in Children
Official title: MAST - Magnesium for Sickle Cell Acute Crisis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia, Sickle Cell
Keywords: Anemia, Sickle Cell
Magnesium Sulfate
pediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2006-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Length of stay in the hospital
timeFrame: Time frame determined by outcome
Secondary outcomes:
measure: Reduction mean daily pain score during an admission for sickle cell pain crisis
timeFrame: Length of hospital stay
measure: Adverse events during admission
timeFrame: Length of hospital stay
measure: Cumulative Narcotic drug required to manage the crises during admission
timeFrame: Length of hospital stay
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jeremy Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.