Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2026-01-01
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Magnesium Sulfate Arm
Pediatric Burn Patients receiving Ketamine as primary agent for sedated dressing changes, randomized (max 5 randomizations) to either study intervention (Magnesium sulfate) or placebo (Normal saline)
magnesium sulfate
IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
Normal Saline Placebo Arm
Placebo
Normal Saline (0.9% NaCl)
Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
Interventions
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magnesium sulfate
IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
Normal Saline (0.9% NaCl)
Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
Eligibility Criteria
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Inclusion Criteria
* admission to HCMC Burn Unit
* Projected multi-day sedated dressing change requirement
* Intention for IV Ketamine as primary analgosedative agent
Exclusion Criteria
* Evidence of hypermagnesemia - pre-study serum Mg2+ level \> 2.5 mg/dL
* Evidence of renal dysfunction - serum Cr level \> 1.5x hospital upper limit normal for age
* Presence of neuromuscular disease (specifically myasthenia gravis), underlying bradyarrhythmia or heart block
* Bronchospastic disease (asthma, reactive airway disease) which requires continuous magnesium sulfate infusion
* Active prescription of a calcium channel blocker (amlodipine, isradipine, nicardipine, nifedipine, clevidipine, diltiazem, verapamil), cardiac glycoside (digoxin), parenteral nutrition or an infusion for hemodynamic support (epinephrine, norepinephrine, dopamine, dobutamine, milrinone, etc)
* Known allergy or reaction to magnesium sulfate, aluminum, or a component of the formulation
* Presence of invasive mechanical ventilation
* Anticipation of skin grafting within 5 days of study eligibility
* Anyone whom child protective services are consulted
* Any investigational drug use within 30 days prior to enrollment
* Pregnant or lactating females
* Anyone whom in the opinion of the investigator is at higher than anticipated risk of harm or inability to adhere to protocol
* Patients who choose to opt out of research
3 Years
18 Years
ALL
No
Sponsors
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Hennepin Healthcare Research Institute
OTHER
Responsible Party
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Joseph Resch
PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship
Locations
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Hennepin County Medical Center
Minneapolis, Minnesota, United States
Countries
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Facility Contacts
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Other Identifiers
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HCMC Pediatric Burn Study
Identifier Type: -
Identifier Source: org_study_id
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