Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The compliance to anesthesia induction in pediatric patients.
研究概览
简要总结
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
详细描述
The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.
The primary outcomes:
- Ease of parenteral separation.
- The compliance to anesthesia induction in pediatric patients.
The secondary outcomes:
- Assessment of postoperative pain.
- Time to first analgesic request.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA: class l
- •Sex: male and female
- •Age: from 3 to 10 years old
- •Children scheduled for adenotonsillectomy
排除标准
- •All children with a history of chronic illness, or developmental delay were excluded from the study
- •History of an autoimmune disease
- •Concurrent use of immunosuppressive treatment
- •Sleep disturbances, speech or communication problems
- •allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
- •hydroxyzine is contraindicated in patients with acute porphyria
研究组 & 干预措施
placebo
10ml apple juice one hour before induction of anesthesia
干预措施: Placebo (Other)
Melatonin
Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia
干预措施: Melatonin 3 MG (Drug)
Hydroxyzine
Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia
干预措施: Hydroxyzine Pill (Drug)
结局指标
主要结局
The compliance to anesthesia induction in pediatric patients.
时间窗: one hour after administration
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
Ease of parenteral separation.
时间窗: 20-30 minutes after administration
Recorded as excellent, good, fair, or poor when the child is separated from the parent
次要结局
- First analgesic request(Three hours postoperative)
- Assessment of postoperative pain(immediately before and at induction procedure)
研究者
Sarah Mohamed Aly Omar Mousa
Dr
Minia University