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
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