Pediatric Burns
Conditions
Keywords
magnesium sulfate, pediatrics, burn, analgesia, sedation, burn dressing change
Brief summary
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
DRUGmagnesium sulfate
IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
DRUGNormal Saline (0.9% NaCl)
Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extra Blood Draws | Through Study Completion, Approximately 1 year | Number of Extra Blood Draws per Patient |
| Study Duration Indicator | Through Study Completion, Approximately 1 year | Duration to Reach Enrollment Target (months) |
| Effectiveness of Drug Delivery & Timing | Through Study Completion, Approximately 1 year | Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes) |
| Severe Adverse Events | Through Study Completion, Approximately 1 year | Frequency of severe adverse events |
| Protocol Deviations | Through Study Completion, Approximately 1 year | Number of Protocol Deviations |
| Consent Rate | Through Study Completion, Approximately 1 year | Consent Rate (%) |
| Enrollment Effort | Through Study Completion, Approximately 1 year | Enrollment Effort of Study Personnel (hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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. |
| Ketamine dosage | Through Study Completion, Approximately 1 year | Cumulative dose requirement of ketamine during sedated dressing change (mg/kg) |
Countries
United States
Outcome results
None listed