Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.
详细描述
Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.
In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.
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
- 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.
- •American Society of Anesthesiology (ASA) physical status I, II.
- •Pediatric patients undergoing squint surgeries.
排除标准
- •Patients who had received any medication with antiemetic properties within 24 h before surgery.
- •Post-operative period (for reasons other than rescue antiemetic therapy).
- •Patients with known liver or renal disease.
- •Patients with a history of vomiting or retching within 24 h before surgery.
研究组 & 干预措施
Group S (Ondansetron lozenge)
Pediatric patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.
干预措施: Ondansetron lozenge (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 24 hours postoperatively
The incidence of postoperative nausea and vomiting (PONV) will be measured in the first 24 postoperative hours at the intervals of 0-2h (early PONV), 2-12h (delayed PONV), and 12- 24h (late PONV)
次要结局
- Incidence of oculo-cardiac reflex (OCR)(24 hours postoperatively)
- Time to onset of emesis(24 hours postoperatively)
- Severity of postoperative nausea and vomiting (PONV)(24 hours postoperatively)
- Number of emetic episodes(24 hours postoperatively)
- Parental satisfaction(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