[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602690":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":63,"overallOfficials":38,"centralContacts":38,"locations":73,"responsibleParty":93,"collaborators":38,"id":97,"slug":38,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":38,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":38,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":121,"whyStopped":38,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Hennepin Healthcare Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":38},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Severe Adverse Events","Frequency of severe adverse events","Through Study Completion, Approximately 1 year",{"measure":14,"description":15,"timeFrame":12},"Protocol Deviations","Number of Protocol Deviations",{"measure":17,"description":18,"timeFrame":12},"Consent Rate","Consent Rate (%)",{"measure":20,"description":21,"timeFrame":12},"Enrollment Effort","Enrollment Effort of Study Personnel (hours)",{"measure":23,"description":24,"timeFrame":12},"Study Duration Indicator","Duration to Reach Enrollment Target (months)",{"measure":26,"description":27,"timeFrame":12},"Effectiveness of Drug Delivery & Timing","Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)",{"measure":29,"description":30,"timeFrame":12},"Extra Blood Draws","Number of Extra Blood Draws per Patient",[32,35],{"measure":33,"description":34,"timeFrame":12},"Ketamine dosage","Cumulative dose requirement of ketamine during sedated dressing change (mg\u002Fkg)",{"measure":36,"description":37,"timeFrame":12},"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.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":45},"TRIPLE",[46,47,48],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Pediatric patients (n=10) suffering severe burn, admitted to the burn unit at Hennepin County Medical Center (Minneapolis, MN) meeting specific inclusion\u002Fexclusion criteria will be randomized daily to either intravenous magnesium sulfate (50 mg\u002Fkg, max 2 g) or placebo (normal saline) for up to 5 sedated burn dressing changes. Primary aims will be to evaluate safety\u002Ffeasibility to guide a future larger randomized controlled trial.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Magnesium Sulfate Arm","EXPERIMENTAL","Pediatric Burn Patients receiving Ketamine as primary agent for sedated dressing changes, randomized (max 5 randomizations) to either study intervention (Magnesium sulfate) or placebo (Normal saline)",[56],"Drug: magnesium sulfate",{"label":58,"type":59,"description":60,"interventionNames":61},"Normal Saline Placebo Arm","PLACEBO_COMPARATOR","Placebo",[62],"Drug: Normal Saline (0.9% NaCl)",[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":38},"DRUG","magnesium sulfate","IV Magnesium Sulfate 50 mg\u002Fkg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change",[52],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":38},"Normal Saline (0.9% NaCl)","Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change",[58],[74],{"facility":75,"status":38,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Hennepin County Medical Center","Minneapolis","Minnesota","55415","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-93.26384,44.97997,{"lat":85,"lon":84},[88],{"name":89,"role":90,"phone":91,"phoneExt":38,"email":92},"Joseph Resch, M.D.","CONTACT","612-481-5885","joseph.resch@hcmed.org",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Joseph Resch","PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship","100602690",false,"NCT07126795","Magnesium Sulfate in Pediatric Burn Dressing Changes","Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study","Inclusion Criteria:\n\n* \\\u003C 18 years old at time of randomization completion\n* admission to HCMC Burn Unit\n* Projected multi-day sedated dressing change requirement\n* Intention for IV Ketamine as primary analgosedative agent\n\nExclusion Criteria:\n\n* age \\\u003C 3 years (may lower pending FDA discussions)\n* Evidence of hypermagnesemia - pre-study serum Mg2+ level \\> 2.5 mg\u002FdL\n* Evidence of renal dysfunction - serum Cr level \\> 1.5x hospital upper limit normal for age\n* Presence of neuromuscular disease (specifically myasthenia gravis), underlying bradyarrhythmia or heart block\n* Bronchospastic disease (asthma, reactive airway disease) which requires continuous magnesium sulfate infusion\n* 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)\n* Known allergy or reaction to magnesium sulfate, aluminum, or a component of the formulation\n* Presence of invasive mechanical ventilation\n* Anticipation of skin grafting within 5 days of study eligibility\n* Anyone whom child protective services are consulted\n* Any investigational drug use within 30 days prior to enrollment\n* Pregnant or lactating females\n* Anyone whom in the opinion of the investigator is at higher than anticipated risk of harm or inability to adhere to protocol\n* Patients who choose to opt out of research","ALL","3 Years","18 Years",{"count":107,"type":108},10,"ESTIMATED","INTERVENTIONAL",[111],"PHASE1","Prospective feasibility trial utilizing adjuvant magnesium sulfate for analgesia\u002Fsedation during pediatric sedated burn dressing changes, which is ultimately hypothesized to decrease ketamine and\u002For sedative requirements.",[114],"Pediatric Burns",[66,116,117,118,119,120],"pediatrics","burn","analgesia","sedation","burn dressing change","NOT_YET_RECRUITING","2025-08-16",{"date":124,"type":125},"2025-08-22","ACTUAL",{"date":127,"type":108},"2026-01-01",{"date":129,"type":108},"2027-01-01",{"name":5,"class":6},1]