Topical Ketamine by Neubulization Method in Tonsillectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative analgesic consumption
研究概览
简要总结
The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations
详细描述
In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study
排除标准
- •patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
研究组 & 干预措施
Nebulized ketamine 2mg/kg
nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.
干预措施: Nebulized Ketamine 2mg/kg (Drug)
control group
control group received placebo nebulization
干预措施: saline placebo (Drug)
Intravenous ketamine0.5mg/kg
intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.
干预措施: Intravenous ketamine0.5mg/kg (Drug)
Nebulized ketamine 1mg/kg
nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.
干预措施: Nebulized Ketamine 1mg/kg (Drug)
结局指标
主要结局
Postoperative analgesic consumption
时间窗: 24 hours postoperative
The total amount of analgesics used in the first 24h postoperative in mg.
次要结局
- Postoperative pain scores(24 hours postoperative)
- Ketamine serum levels to exclude systemic absorption of topical ketamine.(120 min after receiving Ketamine)
研究者
Hala Saad Abdel-Ghaffar
MD
Assiut University