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NCT Number: NCT07126795

Magnesium Sulfate in Pediatric Burn Dressing Changes

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location contact

Joseph Resch, M.D.

CONTACT

[email protected]

612-481-5885

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Severe Adverse Events

    Time frame: Through Study Completion, Approximately 1 year

    Frequency of severe adverse events

  2. Protocol Deviations

    Time frame: Through Study Completion, Approximately 1 year

    Number of Protocol Deviations

  3. Consent Rate

    Time frame: Through Study Completion, Approximately 1 year

    Consent Rate (%)

  4. Enrollment Effort

    Time frame: Through Study Completion, Approximately 1 year

    Enrollment Effort of Study Personnel (hours)

  5. Study Duration Indicator

    Time frame: Through Study Completion, Approximately 1 year

    Duration to Reach Enrollment Target (months)

  6. Effectiveness of Drug Delivery & Timing

    Time frame: Through Study Completion, Approximately 1 year

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

  7. Extra Blood Draws

    Time frame: Through Study Completion, Approximately 1 year

    Number of Extra Blood Draws per Patient

Secondary outcomes

  1. Ketamine dosage

    Time frame: Through Study Completion, Approximately 1 year

    Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)

  2. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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