Magnesium Sulfate in Pediatric Burn Dressing Changes

NCT07126795 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HCMC Pediatric Burn Study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Burns

Keywords

magnesium sulfate; pediatrics; burn; analgesia; sedation; burn dressing change

Outcome Measures

Primary Outcomes (7)

• Severe Adverse Events

  Frequency of severe adverse events

  Through Study Completion, Approximately 1 year

• Protocol Deviations

  Number of Protocol Deviations

  Through Study Completion, Approximately 1 year

• Consent Rate

  Consent Rate (%)

  Through Study Completion, Approximately 1 year

• Enrollment Effort

  Enrollment Effort of Study Personnel (hours)

  Through Study Completion, Approximately 1 year

• Study Duration Indicator

  Duration to Reach Enrollment Target (months)

  Through Study Completion, Approximately 1 year

• Effectiveness of Drug Delivery & Timing

  Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)

  Through Study Completion, Approximately 1 year

• Extra Blood Draws

  Number of Extra Blood Draws per Patient

  Through Study Completion, Approximately 1 year

Secondary Outcomes (2)

• Ketamine dosage

  Through Study Completion, Approximately 1 year

• Adverse Events

  Through Study Completion, Approximately 1 year

Study Arms (2)

Magnesium Sulfate Arm

EXPERIMENTAL

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)

Drug: magnesium sulfate

Normal Saline Placebo Arm

PLACEBO COMPARATOR

Placebo

Drug: Normal Saline (0.9% NaCl)

Interventions

magnesium sulfate DRUG

IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change

Magnesium Sulfate Arm

Normal Saline (0.9% NaCl) DRUG

Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change

Normal Saline Placebo Arm

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Burns; Agnosia

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)