Magnesium Sulfate for Adjuvant Analgesia in Pediatric Burn Dressing Changes: a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Severe Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 18 years old at time of randomization completion
- •admission to HCMC Burn Unit
- •Projected multi-day sedated dressing change requirement
- •Intention for IV Ketamine as primary analgosedative agent
排除标准
- •age < 3 years (may lower pending FDA discussions)
- •Evidence of hypermagnesemia - pre-study serum Mg2+ level > 2.5 mg/dL
- •Evidence of renal dysfunction - serum Cr level > 1.5x hospital upper limit normal for age
- •Presence of neuromuscular disease (specifically myasthenia gravis), underlying bradyarrhythmia or heart block
- •Bronchospastic disease (asthma, reactive airway disease) which requires continuous magnesium sulfate infusion
- •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)
- •Known allergy or reaction to magnesium sulfate, aluminum, or a component of the formulation
- •Presence of invasive mechanical ventilation
- •Anticipation of skin grafting within 5 days of study eligibility
- •Anyone whom child protective services are consulted
- •Any investigational drug use within 30 days prior to enrollment
- •Pregnant or lactating females
- •Anyone whom in the opinion of the investigator is at higher than anticipated risk of harm or inability to adhere to protocol
- •Patients who choose to opt out of research
研究组 & 干预措施
Magnesium Sulfate Arm
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)
干预措施: magnesium sulfate (Drug)
Normal Saline Placebo Arm
Placebo
干预措施: Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Severe Adverse Events
时间窗: Through Study Completion, Approximately 1 year
Frequency of severe adverse events
Protocol Deviations
时间窗: Through Study Completion, Approximately 1 year
Number of Protocol Deviations
Consent Rate
时间窗: Through Study Completion, Approximately 1 year
Consent Rate (%)
Enrollment Effort
时间窗: Through Study Completion, Approximately 1 year
Enrollment Effort of Study Personnel (hours)
Study Duration Indicator
时间窗: Through Study Completion, Approximately 1 year
Duration to Reach Enrollment Target (months)
Effectiveness of Drug Delivery & Timing
时间窗: Through Study Completion, Approximately 1 year
Magnesium Sulfate Completion Timing, Relative to Sedation Start Time (minutes)
Extra Blood Draws
时间窗: Through Study Completion, Approximately 1 year
Number of Extra Blood Draws per Patient
次要结局
- Ketamine dosage(Through Study Completion, Approximately 1 year)
- Adverse Events(Through Study Completion, Approximately 1 year)
研究者
Joseph Resch
PICU Physician, Assistant Professor, Associate Program Director, PCCM Fellowship
Hennepin Healthcare Research Institute