Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Clinical Trial
Study Details
Enrollment
208
Interventions
Description

40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Name
Intravenous Magnesium Sulfate
Type
Drug
Description

(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Name
Normal Saline Placebo
Type
Drug
Phase
Phase 2
Phase 3
Status
COMPLETED
Study ID #
NCT01197417
Study Type
Interventional
Summary

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.

Study Overview
Conditions
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.

Contacts and Locations
Locations
Facility

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States

GeoPoint
41.85003, -87.65005
Facility

Johns Hopkins Hospital
Baltimore, Maryland 21287
United States

GeoPoint
39.29038, -76.61219
Facility

Children's Hospital of Michigan
Detroit, Michigan 48201
United States

GeoPoint
42.33143, -83.04575
Facility

Nationwide Children's Hospital
Columbus, Ohio 43205
United States

GeoPoint
39.96118, -82.99879
Facility

Children's Hospital of Philadelphia Research Institute
Philadelphia, Pennsylvania 19104
United States

GeoPoint
39.95238, -75.16362
Facility

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States

GeoPoint
40.44062, -79.99589
Facility

Baylor College of Medicine
Houston, Texas 77030
United States

GeoPoint
29.76328, -95.36327
Facility

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States

GeoPoint
43.0389, -87.90647