Comparison Of Oral Premedication In Children With Midazolam, Dexmedetomidine And Melatonin For Ease Of Separation From Parents Before Anesthesia : A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Ease Of Separation From Parents By A Scale
研究概览
简要总结
All children undergoing elective surgeries requiring premedication will be explained in detail.
Eligible children will be recruited consecutively and will be randomized using computer generated random envelope method. The random allocation sequence will be generated by the support staff of the institute who will not be part of the study.
Children will be randomly divided into 3 groups,
Group M – Children receiving oral midazolam
Group MT– Children receiving oral melatonin
Group D- Children receiving oral dexmedetomidine
All children will be assessed preoperatively, will have to undergo basic investigations (CBC, Coagulation profile, ECG,CXR)and written consent will be obtained .
Basal heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial pressure, oxygen saturation, respiratory rate will be recorded in premedication room before giving premedication.
Group M children will receive oral Midazolam 0.5mg/kg .
Group MT children will receive oral Melatonin 0.5mg/kg .
Group D children will receive oral Dexmedetomidine 2.5mcg/kg .
Basal heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial pressure, oxygen saturation, respiratory rate and ETCO2 will be recorded every 15 mins from the administration of premedication .
The score for ease of separation from parent will be recorded after 60 mins from the administration of premedication.
The score for Preoperative Anxiety will be assessed after 60 mins from the administration of premedication using modified yale preoperative anxiety scale.
Sedation will be reassessed 60 mins after the premedication using observer sedation score.
Mask acceptance scores will also be recorded after 60 mins from the administration of premedications .
Basal heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial pressure,oxygen saturation ,respiratory rate ,etco2 will be recorded postoperatively for 1 hour in the recovery room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 2 to 6 years.
- •Undergoing Elective surgery.
- •Children Assessed under ASA I ,II.
排除标准
- •Children with difficult airway.
- •Children with intellectual Disability .
- •ADHD and other psychiatric / Sleep disorders.
- •Children with pre existing liver ,Renal ,Heart problems.
- •Children whose parents/Guardians are not willing for the consent and the study.
结局指标
主要结局
Ease Of Separation From Parents By A Scale
时间窗: 60 Mins After Drug Adminstration
次要结局
- Preoperative Anxiety By Modified Yale Scale(60 Mins After Drug Adminstration)
- Sedation By Observer Sedation Score(60 Mins After Drug Adminstration)
- Mask Acceptance By Mask Acceptance Score(60 Mins After Drug Adminstration)
- Hemodynamics(Perioperatively Every 15 Mins Once And Continued Till 1hour Post Opertaive)
研究者
Agathiyan A
srm medical college