A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children | oneSCDvoice
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abstracts & posters

A Multi-Center Randomized Controlled Trial of Intravenous Magnesium for Sickle Cell Pain Crisis in Children

key information

source: Blood

year: 2014

authors: David C. Brousseau, J. Paul Scott, Oluwakemi Badaki, Deepika S. Darbari, Corrie Chumpitazi, Gladstone E. Airewele, Angela M. Ellison , Kim Smith-Whitley, Prashant Mahajan, Sharada A. Sarnaik, T Charles Casper, Larry J. Cook, Michael Dean, Julie Leonard, Monica L. Hulbert, Elizabeth Powell, Robert I. Liem , Robert Hickey, Lakshmanan Krishnamurti, Cheryl A. Hillery , Julie A. Panepinto

summary/abstract:

Introduction: There are approximately 18,000 hospitalizations and 75,000 hospitalization days annually in the United States for children experiencing sickle cell vasoocclusive crises. Despite advances in the management of other comorbidities of sickle cell disease, little has changed in the management of sickle cell pain crises. Magnesium, a known vasodilator, anti-inflammatory and pain reliever, has the potential to alter the pathophysiology of pain crises, shortening length of stay and decreasing opioid use. A previous pilot study showed IV magnesium shortened length of stay compared to historical controls. A randomized trial conducted in Canada showed no decrease in length of stay with the use of intravenous magnesium. In the MAGiC (MAGnesium for children in Crisis) study, we hypothesized that the addition of intravenous (IV) magnesium to standard therapy would shorten hospital length of stay, result in decreased opioid use and improve quality of life for pediatric patients hospitalized with sickle cell pain crises.

Methods: The MAGiC study was a multi-center, randomized, double-blind, placebo-controlled trial of IV magnesium versus normal saline for the treatment of pediatric sickle cell pain crisis conducted at 8 sites. Participating sites were members of the Pediatric Emergency Care Applied Research Network (PECARN), and collaborations between Pediatric Emergency Medicine physicians and Pediatric sickle cell experts facilitated enrollment. Children aged 4 to 21 years, with hemoglobin SS or hemoglobin SB° thalassemia were eligible if they required inpatient hospitalization after failing emergency department (ED) management for pain. Enrollment occurred at 8 sites between December 2010 and December 2013, with a total of 217 eligible site enrollment months. Children received 40 mg/kg of IV magnesium every eight hours for a total of 6 doses or normal saline placebo of equivalent volume (1 ml/kg). Randomization was stratified by site, age and hydroxyurea use. The primary outcome was length of stay from the time of first drug infusion until 12 hours after the last IV opioid dose or time of discharge, whichever occurred first. Secondary outcomes included opioid use, recorded as morphine equivalents, and quality of life, as measured using the PedsQL Sickle cell disease specific module, fatigue module and generic module. Side effects, specifically hypotension, weakness, warmth on infusion, or the development of acute chest syndrome (ACS) were documented. Using an intention-to-treat analysis, we compared length of stay using a Van Elteren test, stratified by the same factors used to stratify randomization.

organisation: Medical College of Wisconsin/Children's Research Institute of the Children's Hospital of Wisconsin; Blood Research Institute,Milwaukee; Johns Hopkins University, Baltimore; Children's National Medical Center, Washington, DC; Baylor College of medicine/Texas Children's Hospital, Houston; The Children's Hospital of Philadelphia; Wayne State University/Children's Hospital of Michigan; University of Utah; Nationwide Children's Hospital, Columbus; Washington University School of Medicine, St. Louis; Ann and Robert Lurie Children's Hospital of Chicago; University of Pittsburgh medical Center; Children's Hospital of Pittsburgh of UPMC

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