Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Status: | Completed |
---|---|
Conditions: | Anemia |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 4 - 21 |
Updated: | 4/21/2016 |
Start Date: | December 2010 |
End Date: | March 2014 |
The purpose of this study is to determine the safety and efficacy of intravenous magnesium
in shortening the duration of a pain crisis and to determine the health-related quality of
life and short term outcomes of children treated with intravenous magnesium during an acute
pain crisis.
in shortening the duration of a pain crisis and to determine the health-related quality of
life and short term outcomes of children treated with intravenous magnesium during an acute
pain crisis.
It is well known that children with sickle cell disease are at risk for acute pain crises.
The usual treatment for these pain crises, intravenous fluids and pain medicines such as
morphine, has changed little over the past three decades. In a pilot study, the addition of
intravenous magnesium to standard therapy decreased length of stay; however, this study was
not randomized, not blinded, not placebo-controlled, and not adequately powered to assess
safety.
We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about
208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium
sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will
return for a routine clinic visit up to 3 months after discharge for a baseline assessment.
Patients will also complete health-related quality of life measures at 4 timepoints
throughout the study.
The usual treatment for these pain crises, intravenous fluids and pain medicines such as
morphine, has changed little over the past three decades. In a pilot study, the addition of
intravenous magnesium to standard therapy decreased length of stay; however, this study was
not randomized, not blinded, not placebo-controlled, and not adequately powered to assess
safety.
We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about
208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium
sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will
return for a routine clinic visit up to 3 months after discharge for a baseline assessment.
Patients will also complete health-related quality of life measures at 4 timepoints
throughout the study.
Inclusion Criteria:
- age 4-21 years, inclusive
- Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
- failed intravenous opioid pain management in the emergency department prior to the
decision to admit the patient
- admitted to the inpatient unit for sickle cell pain crisis
Exclusion Criteria:
- patient received more than 12 hours of intravenous pain medication prior to
enrollment
- previous enrollment in this study (only one admission per child is eligible)
- history of allergy/intolerance to both intravenous morphine and hydromorphone
- known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
- patient with greater than 10 admissions for pain crisis in the past year
- patient maintained on daily opioids or chronic transfusions for chronic sickle cell
pain
- transfusion within the previous two months
- known kidney or liver failure (elevation of liver function tests does not warrant
exclusion)
- known pulmonary hypertension
- pregnancy
- diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic
instability or sepsis
- current oral magnesium supplementation or current enrollment in another therapeutic
study protocol
- previously diagnosed clinical stroke
- current or planned use of neuromuscular blocker, nifedipine, ritodrine, or
terbutaline
- allergy to magnesium sulfate
- discharge from an inpatient unit within 72 hours of arrival in the emergency
department for the current pain crisis
We found this trial at
8
sites
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
![Ann & Robert H. Lurie Children's Hospital of Chicago](/wp-content/uploads/logos/ann-robert-h-lurie-children-s-hospital-of-chicago.jpg)
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)