MAST - Magnesium for Sickle Cell Acute Crisis in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Length of stay in the hospital
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
干预措施: Magnesium Sulfate (Drug)
2
干预措施: Normal Saline (Drug)
结局指标
主要结局
Length of stay in the hospital
时间窗: Time frame determined by outcome
次要结局
- Adverse events during admission(Length of hospital stay)
- Reduction mean daily pain score during an admission for sickle cell pain crisis(Length of hospital stay)
- Cumulative Narcotic drug required to manage the crises during admission(Length of hospital stay)