Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Incidence of shivering
研究概览
简要总结
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in tonsillectomy.
详细描述
Tonsillectomy is one of the most common surgeries in children. The main reason for morbidity in patients undergoing surgical procedures is post-operative complications.
Shivering is random spontaneous and asynchronous skeletal muscle contractions that increases the basal metabolism and is characterized to be a defense mechanism for regulation of temperature.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation.
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
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 4 to 15 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Children undergoing tonsillectomy under general anesthesia.
排除标准
- •Allergy to ondansetron.
- •History of sleep apnea.
- •Cardiac and respiratory diseases.
- •Upper respiratory tract infection.
- •Taking corticosteroids.
结局指标
主要结局
Incidence of shivering
时间窗: 24 hours postoperatively
Incidence of shivering will be recorded and graded by using the scale validated by Crossley and Mahajan. Crossley and Mahajan grade 0, no shivering; grade 1, no visible muscle activity, but one or more of the following: piloerection, peripheral vasoconstriction, or peripheral cyanosis (other causes excluded); grade 2, muscular activity in only one muscle group; grade 3, moderate muscular activity in more than one muscle group but not generalized shaking; grade 4, violent muscular activity that involves the whole body.
次要结局
- Incidence of postoperative nausea and vomiting(24 hours postoperatively)
- Core temperature(Intraoperatively)
- Peripheral temperature(Intraoperatively)
- Incidence of adverse effects(24 hours postoperatively)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University