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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Severe Adverse Events
Frequency of severe adverse events
Time frame: Through Study Completion, Approximately 1 year
Protocol Deviations
Number of Protocol Deviations
Time frame: Through Study Completion, Approximately 1 year
Consent Rate
Consent Rate (%)
Time frame: Through Study Completion, Approximately 1 year
Enrollment Effort
Enrollment Effort of Study Personnel (hours)
Time frame: Through Study Completion, Approximately 1 year
Study Duration Indicator
Duration to Reach Enrollment Target (months)
Time frame: Through Study Completion, Approximately 1 year
Effectiveness of Drug Delivery & Timing
Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Time frame: Through Study Completion, Approximately 1 year
Extra Blood Draws
Number of Extra Blood Draws per Patient
Time frame: Through Study Completion, Approximately 1 year
Ketamine dosage
Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)
Time frame: Through Study Completion, Approximately 1 year
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Adverse Events
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.
Time frame: Through Study Completion, Approximately 1 year