Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in mYPAS
研究概览
简要总结
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
详细描述
The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medication (ketamine versus midazolam) will be drawn up in unmarked syringe and applied to the patient by mucosal atomization device by a nurse not directly involved in the investigation or the patient's care.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 2 to 12 years who present to the ED
- •Requiring intravenous access
- •Requiring laceration repairs
- •Requiring incision and drainage of abscesses
- •Requiring digital nerve blocks
- •Requiring radiological imaging
- •Requiring bladder catheterization
- •Requiring foreign body removal.
排除标准
- •Vital sign abnormalities greater than 20% deviation from age-normalized ranges
- •Altered mental status/delirium or intoxication
- •Patient or patient's parent/guardian are unwilling to participate or provide informed consent
- •Any allergy to ketamine or midazolam
- •Patient is female with history of menarche
- •Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
- •Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
- •Presence of intracranial mass or vascular lesion.
- •Presence of a history of psychosis or hallucinations
- •Weight greater than 100kg
- •History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
- •Non-English speaking/reading parent/guardian and/or patients
- •Patient is acutely psychotic
- •Provider feels that patient currently or likely will require chemical and/or physical restraints
- •History of prolonged QT-interval
- •Nasal trauma
- •Epistaxis
研究组 & 干预措施
Ketamine
Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device.
干预措施: Ketamine 100 MG/ML (Drug)
Midazolam
Midazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device.
干预措施: Midazolam 5 MG/ML (Drug)
结局指标
主要结局
Change in mYPAS
时间窗: Change in score between initial measurement versus 5 minutes pre-procedure
Modified Yale preoperative anxiety scale
次要结局
- Change in pain rating (Wong-Baker Pain Faces Rating Scale)(Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge)
- Change in anxiety score (Visual analogue scale)(Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge)
- Change in sedation scale(Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge)
研究者
Michael D. April
Assistant Program Director for Research, EM Residency
Brooke Army Medical Center