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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Normal Saline Placebo Arm | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium sulfate | Drug | IV Magnesium Sulfate 50 mg/kg (max 2 grams) over 20 minutes given immediately prior to initiation of daily sedated dressing change |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe Adverse Events | Frequency of severe adverse events | Through Study Completion, Approximately 1 year |
| Protocol Deviations | Number of Protocol Deviations | Through Study Completion, Approximately 1 year |
| Consent Rate | Consent Rate (%) | Through Study Completion, Approximately 1 year |
| Enrollment Effort | Enrollment Effort of Study Personnel (hours) | Through Study Completion, Approximately 1 year |
| Study Duration Indicator | Duration to Reach Enrollment Target (months) | Through Study Completion, Approximately 1 year |
| Effectiveness of Drug Delivery & Timing | Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes) | Through Study Completion, Approximately 1 year |
| Extra Blood Draws | Number of Extra Blood Draws per Patient | Through Study Completion, Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Ketamine dosage | Cumulative dose requirement of ketamine during sedated dressing change (mg/kg) | Through Study Completion, Approximately 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Normal Saline (0.9% NaCl) | Drug | Normal Saline given in equivalent volume as study drug over 20 minutes, immediately prior to initiation of sedated dressing change |
|
| Through Study Completion, Approximately 1 year |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |