Phase 3 N=208 Randomized Triple-blind Treatment

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Sickle Cell Disease

Bottom Line

View on ClinicalTrials.gov: NCT01197417 ↗

Enrolled (actual)

208

Serious AEs

12.3%

Results posted

Sep 2015

Primary outcome: Primary: Hospital Length of Stay (Hours) — 56; 47 hours — p=0.24

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Intravenous Magnesium Sulfate (Drug); Normal Saline Placebo (Drug)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Length of Stay (Hours)	56; 47	0.24
SECONDARY Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization	1.46; 1.28	0.12
SECONDARY Hypotension Associated With Infusion	4; 1	0.39
SECONDARY Warm Sensation Associated With Study Drug Infusion	26; 2	<0.01 sig
SECONDARY Rehospitalization	12; 7	0.11
SECONDARY Development of Acute Chest Syndrome (ACS)	16; 14	0.78
SECONDARY Hospital Length of Stay	74.5; 60.5	0.46

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01197417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.