Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
NCT Number: NCT07126795
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.
Trial opening soon.
Get Notified3 year–18 year
All sexes
Interventional
Phase 1
Minneapolis, Minnesota, 55415, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Through Study Completion, Approximately 1 year
Frequency of severe adverse events
Time frame: Through Study Completion, Approximately 1 year
Number of Protocol Deviations
Time frame: Through Study Completion, Approximately 1 year
Consent Rate (%)
Time frame: Through Study Completion, Approximately 1 year
Enrollment Effort of Study Personnel (hours)
Time frame: Through Study Completion, Approximately 1 year
Duration to Reach Enrollment Target (months)
Time frame: Through Study Completion, Approximately 1 year
Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Time frame: Through Study Completion, Approximately 1 year
Number of Extra Blood Draws per Patient
Time frame: Through Study Completion, Approximately 1 year
Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)
Time frame: 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.
Hennepin Healthcare Research Institute
Other
Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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