Anemia, Sickle Cell
Conditions
Keywords
Anemia, Sickle Cell, Magnesium Sulfate, pediatric
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.
Interventions
DRUGMagnesium Sulfate
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
DRUGNormal Saline
Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
Sponsors
The Physicians' Services Incorporated Foundation
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of stay in the hospital | Time frame determined by outcome |
Secondary
| 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 |
Countries
Canada
Outcome results
None listed