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
Qualifiers
< 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
Treatments tested in this trial
- magnesium sulfate
- Normal Saline (0.9% NaCl)
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov