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Completed

NCT Number: NCT00313963

MAST - Magnesium for Sickle Cell Acute Crisis in Children

The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.

In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known sickle cell disease
  • Previous painful crisis resulting in an Emergency Department(ED) visit
  • Current visit with a chief complaint of pain
  • Age 4 years - 18 years
  • Staff ED decides to admit to the hospital
  • Staff ED decides to start an intravenous line

Exclusion criteria

  • Fever (>38.5C) during the 24 hours prior to visit at triage
  • Patients transfused within 90 days of study entry
  • Patients with known renal disease
  • Patients with known heart block or myocardial damage
  • Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
  • Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
  • Patients or parents unable to communicate in English
  • Known pregnancy
  • Known allergy to Magnesium
  • Admission to the ICU
  • Enrolment to the study in the last 30 days

Treatment and study plan

Magnesium sulfate

Drug

Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.

normal saline

Drug

Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.

Primary outcomes

  1. Length of stay in the hospital

    Time frame: Time frame determined by outcome

Secondary outcomes

  1. Reduction mean daily pain score during an admission for sickle cell pain crisis

    Time frame: Length of hospital stay

  2. Adverse events during admission

    Time frame: Length of hospital stay

  3. Cumulative Narcotic drug required to manage the crises during admission

    Time frame: Length of hospital stay

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2013
First posted
Apr 12, 2006
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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