Not Yet RecruitingPhase 1Other

Magnesium Sulfate in Pediatric Burn Dressing Changes

Sponsored by Hennepin Healthcare Research Institute

NCT ID
NCT07126795
Target Enrollment
10 participants
Start Date
2026-01-01
Est. Completion
2027-01-01

About This Study

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 Studied

Pediatric Burns

Interventions

  • magnesium sulfate
  • Normal Saline (0.9% NaCl)

Eligibility

Age:3 Years - 18 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

Hennepin County Medical Center
Minneapolis, Minnesota, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source