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Not yet recruiting NCT07126795

Magnesium Sulfate in Pediatric Burn Dressing Changes

Phase I Interventional Pediatric Burns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: magnesium sulfate, Normal Saline (0.9% NaCl).
Who it may be relevant to
Registry conditions: Pediatric Burns. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Severe Adverse Events [Time frame: Through Study Completion, Approximately 1 year]
  • Protocol Deviations [Time frame: Through Study Completion, Approximately 1 year]
  • Consent Rate [Time frame: Through Study Completion, Approximately 1 year]
  • Enrollment Effort [Time frame: Through Study Completion, Approximately 1 year]
  • Study Duration Indicator [Time frame: Through Study Completion, Approximately 1 year]
  • Effectiveness of Drug Delivery & Timing [Time frame: Through Study Completion, Approximately 1 year]
  • Extra Blood Draws [Time frame: Through Study Completion, Approximately 1 year]
Secondary outcome measures (2)
  • Ketamine dosage [Time frame: Through Study Completion, Approximately 1 year]
  • Adverse Events [Time frame: Through Study Completion, Approximately 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hennepin County Medical Center — Minneapolis

Identifiers

NCT: NCT07126795 · HCMC Pediatric Burn Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗