A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score: Visual analog score (VAS)- by a parent
研究概览
简要总结
Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery
Hypothesis:
Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.
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)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child with laceration requiring sedation
排除标准
- •Major trauma
- •Closed head injury associated with loss of consciousness
- •Abnormal neurologic examination in a previously normal child
- •Significant developmental delay or baseline neurological deficit
- •A patient with seizures
- •Elevated intra-cranial pressure
- •Hypersensitivity to midazolam or ketamine
- •Hypertension
- •Hyperthyroidism or a patient receiving thyroid replacement
- •alcohol intoxication or a history of alcohol abuse
- •Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
- •Known psychiatric disease
- •American Society of Anesthesiologists (ASA) score of more than 2
- •Informed consent cannot be obtained from legal guardian
研究组 & 干预措施
Midazolam
Oral Midazolam
干预措施: Midazolam - active comparator (Drug)
结局指标
主要结局
Pain score: Visual analog score (VAS)- by a parent
时间窗: During the procedure - up to 1 hour
A parent will assess the child's pain on a Visual analog scale
Number of patients requiring IV sedation
时间窗: During the procedure - up to 1 hour
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
次要结局
- • Patients and parents satisfaction assessed on VAS(While in the ED - estimated time around 2 hours)
- UMSS - by ED physician(During the procedure - up to 1 hour)
- • VAS by nurse(During the procedure - up to 1 hour)
- Time to reach UMSS > 2(up to 1 hour)
- • Procedure time(During the procedure - up to 1 hour)
- • Time from procedure to full recovery(While in the ED - estimated time around 2 hours)
- The occurrence of adverse effects during the ED stay(While in the ED - estimated time around 2 hours)