Intranasal Dexmedetomidine and Fentanyl Versus Intravenous Midazolam and Ketamine in Sedation for Painful Outpatient Procedures
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sedation
研究概览
简要总结
Pain is a vital sign that depends on personal experience involving different factors such as previous sensory and emotional experience, age, spiritual and cultural aspects, that makes it harder to evaluate, especially in young children. Pain control is important to diminish the anxiety of the child and family, also this is more important in patients who require procedure and treatment that are more painful, like oncological and hematological patients. The study aims to measure if the intranasal drugs (dexmedetomidine and fentanyl) has the same outcomes when compared with intravenous drug (ketamine and midazolam), but with less side effects. The participants are patients from an oncologic outpatient, that will be submitted to cerebrospinal fluid puncture, myelogram or both will be randomized assigned to both groups. The study will compare physiological variables ( heart rate, respiratory rate and blood pressure) and sedation and pain scales to see if its work properly. The study purpose is to evaluate if intranasal drug works in the same way with less side effects comparing with the usual treatment.
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
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with oncohematological diseases that requires cerebrospinal fluid, myelogram or both for staging and monitoring their treatment ( leukemia, lymphoma, solid tumors and bone marrow aplasia)
- •Patients who is undergoing to collect cerebrospinal fluid, myelogram or both;
- •aged between two and eight years;
- •absence of tumor recurrence.
排除标准
- •Previous neurologic disease;
- •Using of opioid previously;
- •Neurological developmental delay
研究组 & 干预措施
intranasal dexmedetomidine and fentanyl
Dexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure
干预措施: intranasal dexmedetomidine (Drug)
intranasal dexmedetomidine and fentanyl
Dexmedetomidine (precedex®) and fentanyl will be administered by intranasal routes, seeing if both sedative (dexmedetomidine) and analgesic (fentanyl) can give enough sedation for procedure
干预措施: intranasal fentanyl (Drug)
intravenous ketamine and midazolam
ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
干预措施: intravenous ketamine (ketalar®) (Drug)
intravenous ketamine and midazolam
ketamine (ketalar®) and midazolam intravenous will be using to compare the efficiency of intranasal drugs
干预措施: intravenous midazolam (Drug)
结局指标
主要结局
Sedation
时间窗: The Ramsay scale will be measure each 2 minutes up to 30 minutes.
Evaluate if intranasal drugs is effective for sedation in painful procedures for paediatric oncologic and hematologic patients. For access this, will be use Ramsay scale, this scale range between 1 to 6. 1 is a anxious patient and 6 sleeping patient without answer
Pain control
时间窗: The FLACC scale will be measure each 2 minutes up to 30 minutes.
Evaluate if intranasal drugs is effective for pain relief in painful procedures for paediatric oncologic and hematologic patients. To measure it will use Face, Legs, Activity, Cry, Consolability scale (FLACC). This is a scale for pain in children, and for each sign gives 0-2 point, and 0 is no pain and 7-10 intense pain
Change in heart rate
时间窗: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for ages. To evaluate this, heart rate values will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
Change in respiratory rate
时间窗: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for different ages. To evaluate this, respiratory rate values will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
Change in blood pressure
时间窗: each 2 minutes up to 30 minutes
evaluate side effects using PALS ( paediatric advanced life support) values for ages. To evaluate this, blood pressure value will be noted before the procedure, during and after that and will be evaluated if there was an increase or decrease in it, respecting a significance level of 5%.
次要结局
- Comparison if intranasal drugs has the same sedation effects like intravenous drug(each 2 minutes after medication up to 30 minutes)
- Comparison if intranasal drugs has the same pain relief as intravenous drugs(each 2 minutes up to 30 minutes)
研究者
Eduardo Juan Troster
Associate Professor
University of Sao Paulo General Hospital