Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

Medical College of Wisconsin

Status and phase

Completed

Phase 3

Phase 2

Conditions

Sickle Cell Disease

Treatments

Drug: Intravenous Magnesium Sulfate

Drug: Normal Saline Placebo

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT01197417

PECARN 025

Details and patient eligibility

About

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.

Full description

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.

Enrollment

208 patients

Sex

All

Ages

4 to 21 years old

Volunteers

No Healthy Volunteers

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