Magnesium Sulfate in Pediatric Burn Dressing Changes

Not Applicable

Not yet recruiting

• Conditions: Pediatric Burns
• Interventions: Drug: magnesium sulfate; Drug: Normal Saline (0.9% NaCl)

• Registration Number: NCT07126795
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-16
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-22
• Study Start: 2026-01-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate Arm	magnesium sulfate	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)
Normal Saline Placebo Arm	Normal Saline (0.9% NaCl)	Placebo

Primary Outcome Measures

Name	Time	Method
Severe Adverse Events	Through Study Completion, Approximately 1 year	Frequency of severe adverse events
Protocol Deviations	Through Study Completion, Approximately 1 year	Number of Protocol Deviations
Consent Rate	Through Study Completion, Approximately 1 year	Consent Rate (%)
Enrollment Effort	Through Study Completion, Approximately 1 year	Enrollment Effort of Study Personnel (hours)
Study Duration Indicator	Through Study Completion, Approximately 1 year	Duration to Reach Enrollment Target (months)
Effectiveness of Drug Delivery & Timing	Through Study Completion, Approximately 1 year	Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Extra Blood Draws	Through Study Completion, Approximately 1 year	Number of Extra Blood Draws per Patient

Secondary Outcome Measures

Name	Time	Method
Ketamine dosage	Through Study Completion, Approximately 1 year	Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)
Adverse Events	Through Study Completion, Approximately 1 year	Specific tracking of adverse events related to Magnesium sulfate and deep sedative agents. General tracking of adverse events. Description of severity and relation to magnesium sulfate.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States