Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-03 @ 1:55 AM
Study NCT ID:
NCT07126795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate in Pediatric Burn Dressing Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-16', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Adverse Events', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Frequency of severe adverse events'}, {'measure': 'Protocol Deviations', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Number of Protocol Deviations'}, {'measure': 'Consent Rate', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Consent Rate (%)'}, {'measure': 'Enrollment Effort', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Enrollment Effort of Study Personnel (hours)'}, {'measure': 'Study Duration Indicator', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Duration to Reach Enrollment Target (months)'}, {'measure': 'Effectiveness of Drug Delivery & Timing', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)'}, {'measure': 'Extra Blood Draws', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Number of Extra Blood Draws per Patient'}], 'secondaryOutcomes': [{'measure': 'Ketamine dosage', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': 'Cumulative dose requirement of ketamine during sedated dressing change (mg/kg)'}, {'measure': 'Adverse Events', 'timeFrame': 'Through Study Completion, Approximately 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['magnesium sulfate', 'pediatrics', 'burn', 'analgesia', 'sedation', 'burn dressing change'], 'conditions': ['Pediatric Burns']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 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 \\< 3 years (may lower pending FDA discussions)\n* Evidence of hypermagnesemia - pre-study serum Mg2+ level \\> 2.5 mg/dL\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'}, 'identificationModule': {'nctId': 'NCT07126795', 'briefTitle': 'Magnesium Sulfate in Pediatric Burn Dressing Changes', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study', 'orgStudyIdInfo': {'id': 'HCMC Pediatric Burn Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium Sulfate Arm', 'description': '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)', 'interventionNames': ['Drug: magnesium sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline Placebo Arm', 'description': 'Placebo', 'interventionNames': ['Drug: Normal Saline (0.9% NaCl)']}], 'interventions': [{'name': 'magnesium sulfate', 'type': 'DRUG', 'description': 'IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change', 'armGroupLabels': ['Magnesium Sulfate Arm']}, {'name': 'Normal Saline (0.9% NaCl)', 'type': 'DRUG', 'description': 'Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change', 'armGroupLabels': ['Normal Saline Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Joseph Resch, M.D.', 'role': 'CONTACT', 'email': 'joseph.resch@hcmed.org', 'phone': '612-481-5885'}], 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship', 'investigatorFullName': 'Joseph Resch', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}