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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

NCT01197417 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2016-01-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pediatric Emergency Care Applied Research Network

    collaborator NETWORK

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • David Brousseau, MD, MS · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197417 on ClinicalTrials.gov