A comparative study of the efficacy of Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients via intranasal mucosal atomization device.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- This study will help us to know which drug out of two drugs - intranasal fentanyl or
研究概览
简要总结
A comparative study of the efficacy of Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients via intranasal mucosal atomization device.
OBJECTIVES
To compare the efficacy of intranasal fentanyl and intranasal dexmedetomidine, for relieving
pre-operative anxiety in children on the basis of onset and quality of anxiolysis
parental separation
hemodynamic stability
cooperation to mask holding
To compare the onset of action and duration of the sedative effects of each drug
To evaluate the safety of both intranasal fentanyl and intranasal dexmedetomidine as premedication, focusing on the incidence of adverse effects.
Inclusion Criteria:
Children in the age group 3–12 years.
ASA I and II.
Children underwent elective surgery under general anesthesia
Exclusion Criteria:
Children with ASA physical status Classes III and IV
Allergy to the drugs under study
Patients with any intranasal pathology/congenital anomaly of upper airway tract
Patients on anticonvulsant therapy or other sedative medications
Patients undergoing emergency surgeries.
Children with bradycardia Patient fulfilling the above said inclusion criteria will be subjected to study.
Patient will be divided randomly in group D and group F:
Group - D - 1.5 ug/kg intranasally ½dose in each nostril.
Group - F - 1 ug/kg intranasally 1/5 dose in each nostril.
Duration Of Study: 18 Months
Study Site: Dhiraj Hospital, S.B.K.S M.I.R.C. Piparia, Waghodia, Vadodara, Gujarat. Study Design: Randomised, parellel group, active controlled trial
Sample Size: 60 (30 In Each Group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group 3–12 years ASA I and II.
- •Children undergoing elective surgery under general anesthesia.
排除标准
- •Children with ASA physical status Classes III and IV Allergy to the drugs under study Patients with any intranasal pathology/congenital anomaly of upper airway tract Patients on anticonvulsant therapy or other sedative medications Patients undergoing emergency surgeries.
- •Children with bradycardia Patient fulfilling the above said inclusion criteria will be subjected to study.
结局指标
主要结局
This study will help us to know which drug out of two drugs - intranasal fentanyl or
时间窗: every 5 min till 30 min (pre ot) | every 30 min till 2 hours (intra ot)
dexmedetomidine is a better premedication to achieve the better-quality sedation and reducing
时间窗: every 5 min till 30 min (pre ot) | every 30 min till 2 hours (intra ot)
preoperative anxiety in children
时间窗: every 5 min till 30 min (pre ot) | every 30 min till 2 hours (intra ot)
次要结局
- following parameters will be assessed.(1)Anxiety score)
研究者
Rohan Modi
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre