Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of POV after tonsillectomy with or without adenoidectomy
研究概览
简要总结
Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.
详细描述
Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :
- Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia
- Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 2-8 y.
- •children ASA 1-2
- •tonsillectomy with or without adenoidectomy
排除标准
- •American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
- •intravenous induction
- •contraindication to steroids
- •Rash or local infection over an acupuncture point
- •administration of steroids in the 24 hours before the surgery
- •Use of medication with antiemetic effect within the 24 hours before surgery
- •Gastric or intestinal diseases
- •refusal of parents
研究组 & 干预措施
Dexamethasone
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
干预措施: Dexamethasone (Drug)
Acupuncture
Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes
干预措施: Acupuncture (Device)
结局指标
主要结局
Incidence of POV after tonsillectomy with or without adenoidectomy
时间窗: 24 hours postoperatively
by 3 point ordinal scale
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Principal Investigator
Assiut University