Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Intramuscular injection pain
研究概览
简要总结
Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.
详细描述
Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.
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
We will blind medication administrator, care provider, and assessor in addition to the patients.
入排标准
- 年龄范围
- 12 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who need to undergo procedural sedation and analgesia
排除标准
- •Weight over 33 Kg
- •No Consent from parents/patient
- •Needs immediate procedure due to patient's condition
- •Growth/mental retardation
- •Sensory deficit at the site of intramuscular injection
研究组 & 干预措施
Intranasal ketamine
干预措施: Ketamine (Drug)
Intranasal sterile water
干预措施: Sterile water (Drug)
结局指标
主要结局
Intramuscular injection pain
时间窗: immediately after Intramuscular injection
This will be assessed at the time of injection using FLACC scale.
次要结局
- Hospital stay duration(1 hours on average)
- Adverse effects(1 hours on average)
研究者
Hadi Mirfazaelian
Assistant Professor of Emergency Medicine
Tehran University of Medical Sciences