A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) for pain
研究概览
简要总结
This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.
详细描述
In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being ages between 2 and 18
- •undergoing elective surgery
- •intubated patients over 1 hour
- •ASA(American Society of Anesthesiologists) Class I-II patients
排除标准
- •Urgent surgeries
- •Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
研究组 & 干预措施
lidocaine group
10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
干预措施: Lidocaine 10% Spray (Drug)
steroid group
mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
干预措施: Mometasone nasal spray (Drug)
结局指标
主要结局
Visual analog scale (VAS) for pain
时间窗: 24 hours
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
次要结局
未报告次要终点
研究者
ALI ULVI OLC
Principal Investigator
Derince Training and Research Hospital