Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT07126795
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT07126795
Study Brief:
Protocol Section:
NCT07126795