NCT01197417

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 4 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Intravenous Magnesium Sulfate	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
DRUG	Normal Saline Placebo	(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-09-09
• Last updated: 2016-01-27
• Results posted: 2015-09-07

Locations

8 sites across 1 country: United States