CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
Intravenous Magnesium Sulfate +1 moredrug
Likely dose
Intravenous Magnesium Sulfate 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01197417
NCT01197417Phase 3Completed
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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Medical College of Wisconsin·interventional·Posted Sep 9, 2010·Updated Jan 27, 2016

In Brief

A Phase 3 clinical trial evaluating Intravenous Magnesium Sulfate and Normal Saline Placebo for Sickle Cell Disease. Completed, enrolled 208 participants across 8 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
CollaboratorsPediatric Emergency Care Applied Research Network

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2010
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.8 years ago

Interventions

Intravenous Magnesium Sulfatedrug

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

Normal Saline Placebodrug

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