Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

NCT ID: NCT01197417

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Magnesium group

Intravenous Magnesium Sulfate

Group Type: EXPERIMENTAL

Intravenous Magnesium Sulfate

Intervention Type: DRUG

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

Placebo group

Normal Saline placebo

Group Type: PLACEBO_COMPARATOR

Normal Saline Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Normal Saline Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 4-21 years, inclusive
• Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
• failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
• admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria

• patient received more than 12 hours of intravenous pain medication prior to enrollment
• previous enrollment in this study (only one admission per child is eligible)
• history of allergy/intolerance to both intravenous morphine and hydromorphone
• known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
• patient with greater than 10 admissions for pain crisis in the past year
• patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
• transfusion within the previous two months
• known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
• known pulmonary hypertension
• pregnancy
• diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
• current oral magnesium supplementation or current enrollment in another therapeutic study protocol
• previously diagnosed clinical stroke
• current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
• allergy to magnesium sulfate
• discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Emergency Care Applied Research Network

NETWORK

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Brousseau, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia Research Institute

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Brousseau DC, Scott JP, Badaki-Makun O, Darbari DS, Chumpitazi CE, Airewele GE, Ellison AM, Smith-Whitley K, Mahajan P, Sarnaik SA, Casper TC, Cook LJ, Dean JM, Leonard J, Hulbert ML, Powell EC, Liem RI, Hickey R, Krishnamurti L, Hillery CA, Nimmer M, Panepinto JA; Pediatric Emergency Care Applied Research Network (PECARN). A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children. Blood. 2015 Oct 1;126(14):1651-7. doi: 10.1182/blood-2015-05-647107. Epub 2015 Jul 31.

Reference Type: RESULT

PMID: 26232172 (View on PubMed)

Panepinto JA, Paul Scott J, Badaki-Makun O, Darbari DS, Chumpitazi CE, Airewele GE, Ellison AM, Smith-Whitley K, Mahajan P, Sarnaik SA, Charles Casper T, Cook LJ, Leonard J, Hulbert ML, Powell EC, Liem RI, Hickey R, Krishnamurti L, Hillery CA, Brousseau DC; Pediatric Emergency Care Applied Research Network (PECARN). Determining the longitudinal validity and meaningful differences in HRQL of the PedsQL Sickle Cell Disease Module. Health Qual Life Outcomes. 2017 Jun 12;15(1):124. doi: 10.1186/s12955-017-0700-2.

Reference Type: DERIVED

PMID: 28606098 (View on PubMed)

Badaki-Makun O, Scott JP, Panepinto JA, Casper TC, Hillery CA, Dean JM, Brousseau DC; Pediatric Emergency Care Applied Research Network (PECARN) Magnesium in Sickle Cell Crisis (MAGiC) Study Group. Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial. Pediatr Blood Cancer. 2014 Jun;61(6):1049-54. doi: 10.1002/pbc.24925. Epub 2014 Jan 17.

Reference Type: DERIVED

PMID: 24443249 (View on PubMed)

Other Identifiers

PECARN 025

Identifier Type: -

Identifier Source: org_study_id