Comparison of nebulized fentanyl and nebulized midazolam as sedative premedication in pediatric patients : A randomized, double blinded study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time of onset of sedation
研究概览
简要总结
Surgery is a major life experience in a patient’s life, especially in children, as they undergo a stressful pre-operative period mainly due to parental separation. Unfamiliar faces, fear of doctors and needle injection may aggravate their anxiety leading to increased stress response, increased post-operative pain and increased need for analgesia. Thus, pre-operative sedation is necessary for children to allay the fear and decrease the separation anxiety of children from parents and aid in smooth induction.
Several drugs like midazolam, dexmedetomidine, ketamine, fentanyl and chlorhydrate have been used as premedication in children to ease parental separation and relieve anxiety. Midazolam is the most commonly used pre operative sedative. It is a short acting benzodiazepine with anxiolytic, amnestic, hypnotic, anticonvulsant and muscle relaxant actions. Fentanyl is a synthetic opioid with analgesic and sedative property. It has a rapid onset and short duration of action.
Pre medications are most commonly administered via the oral route, intranasal route, intramuscular route and rectal route. Intranasal administration is associated with high bioavailability of the drug and produces effective sedation with least patient discomfort.
Limited studies are available for comparing effects of nebulized fentanyl and midazolam as premedication in children. Hence, the present study has been designed to compare the effects of these drugs as sedative premedication in children undergoing surgery under general anesthesia.
In this research study we hypothesize that fentanyl when compared to midazolam will provide similar onset of sedation but better anxiolysis and shorter duration of action.
This study is a randomized controlled trial with a sample size of 72 and will be conducted in MS Ramaiah Medical College , Bangalore. The primary outcome will be to compare the time of onset of sedation between Fentanyl Group and Midazolam Group. The secondary outcome will be to compare Fentanyl(Group F) and Midazolam (Group M) with respect to
· parental anxiety separation at 30 minutes
· maximum level of sedation at the end of 30 minutes
· mask acceptance scale scores
· hemodynamic parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patients between 2-6 years old undergoing elective surgeries under general anaesthesia Patients belonging to American Society of Anaesthesiologists 1 and 2.
排除标准
- •Patients with difficult airway Patients with central nervous system dysfunction Patients with behavourial disorders Patients with drug allergy Patients with intranasal pathology Patients with congenital anomaly Parent rejection or refusal.
结局指标
主要结局
Time of onset of sedation
时间窗: Time of onset of sedation will be assessed when the sedation score is 3 during premedication (30 minus prior to surgery)
次要结局
- parental anxiety separation at 30 minutes(maximum level of sedation at the end of 30 minutes)
研究者
Dr Harshini V
M S Ramaiah Medical College