Magnesium Sulfate in Pediatric Burn Dressing Changes
ConditionPediatric Burns
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-18
SponsorHennepin Healthcare Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
< 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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
magnesium sulfate
DrugIV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change
Normal Saline (0.9% NaCl)
DrugNormal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Magnesium Sulfate ArmExperimental treatment 1 intervention
Group B: Normal Saline Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Severe Adverse Events
Frequency of severe adverse events
Time frame
Through Study Completion, Approximately 1 year2
Protocol Deviations
Number of Protocol Deviations
Time frame
Through Study Completion, Approximately 1 year3
Consent Rate
Consent Rate (%)
Time frame
Through Study Completion, Approximately 1 year4
Enrollment Effort
Enrollment Effort of Study Personnel (hours)
Time frame
Through Study Completion, Approximately 1 yearSecondary outcomes
1
Ketamine dosage
Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)
Time frame
Through Study Completion, Approximately 1 year2
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 yearSponsors and contacts
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Source ClinicalTrials.gov
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