Clinical Trial
Study Details
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
(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
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
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
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia Research Institute
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States