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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
208
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
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Nationwide Children's Hospital
Hospital Length of Stay (Hours)
Time frame: From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment
Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization
Time frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment
Hypotension Associated With Infusion
For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
Time frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Warm Sensation Associated With Study Drug Infusion
Patient spontaneously reported feelings of warmth during any study drug infusion.
Time frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Rehospitalization
Time frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)
Development of Acute Chest Syndrome (ACS)
Time frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment
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Columbus, Ohio, United States
Children's Hospital of Philadelphia Research Institute
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Length of Stay
Time frame: Start of first study drug infusion to actual hospital discharge