Magnesium Sulfate in Pediatric Burn Dressing Changes

Hennepin Healthcare

Status and phase: Not yet enrolling; Phase 1

Conditions: Pediatric Burns

Treatments: Drug: Normal Saline (0.9% NaCl); Drug: magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT07126795

HCMC Pediatric Burn Study

Details and patient eligibility

About

Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia/sedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and/or sedative requirements.

Full description

Pediatric patients (n=10) suffering severe burn, admitted to the burn unit at Hennepin County Medical Center (Minneapolis, MN) meeting specific inclusion/exclusion criteria will be randomized daily to either intravenous magnesium sulfate (50 mg/kg, max 2 g) or placebo (normal saline) for up to 5 sedated burn dressing changes. Primary aims will be to evaluate safety/feasibility to guide a future larger randomized controlled trial.

Enrollment: 10 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• < 18 years old at time of randomization completion
• admission to HCMC Burn Unit
• Projected multi-day sedated dressing change requirement
• Intention for IV Ketamine as primary analgosedative agent

Exclusion criteria

• age < 3 years (may lower pending FDA discussions)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups, including a placebo group

Magnesium Sulfate Arm

Experimental group

Description:

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)

Treatment:

Drug: magnesium sulfate

Normal Saline Placebo Arm

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Normal Saline (0.9% NaCl)