[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602690":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Hennepin Healthcare Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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)",[13],"Drug: magnesium sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal Saline Placebo Arm","PLACEBO_COMPARATOR","Placebo",[19],"Drug: Normal Saline (0.9% NaCl)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hennepin County Medical Center","Minneapolis","Minnesota","55415","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-93.26384,44.97997,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Joseph Resch, M.D.","CONTACT","612-481-5885","joseph.resch@hcmed.org",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Joseph Resch","PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship","100602690","phase-1-magnesium-sulfate-in-pediatric-burn-dressing-changes-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":66,"type":67},10,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73],"Pediatric Burns",[23,75,76,77,78,79],"pediatrics","burn","analgesia","sedation","burn dressing change","NOT_YET_RECRUITING","2025-08-16",{"date":83,"type":84},"2025-08-22","ACTUAL",{"date":86,"type":67},"2026-01-01",{"date":88,"type":67},"2027-01-01",{"name":5,"class":6},1]