Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group Undergoing Adenotonsillectomy: A Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Preoperative anxiety
研究概览
简要总结
Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.
Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.
Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.
详细描述
Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.
Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.
Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.
The objective of this descriptive study is to compare the efficacy of dexmedetomidine and paracetamol premedication, measuring the degree of anxiety in the children prepared for adenotonsillectomy when they are separated from their parents.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients who are clinically free or with controlled medical condition [ASA I or ASA II].
- •Age between 2 to 8 years.
排除标准
- •ASA III or ASA IV.
- •Age greater than 8 years.
- •Parents' refusal to participate in the study.
- •Patients with obstructive sleep apnea.
- •Patients with known allergy or hypersensitivity reaction to any of the drugs used in the study.
- •Patients with nasal infection or nasal pathology.
研究组 & 干预措施
Group (D)
The patient will receive intranasal dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
Group (P)
The patient will receive paracetamol orally.
干预措施: paracetamol (Drug)
结局指标
主要结局
Preoperative anxiety
时间窗: After 50 minutes of drug administration.
Modified Yale preoperative anxiety score (m-Yale PAS) before intravenous catheterization. In m-Yale PAS, anxiety was assessed based on their activities, (1-4) emotional expression, (1-4) Vocalization, (1-6) state of arousal (1-4) and interaction with family members.(1-4) The minimum of score is five (minimum anxiety) and the maximum is 22 which means severe anxiety.
次要结局
未报告次要终点
研究者
Fatma Ahmed Abdel Fatah
Lecturer
Benha University