The Effect of Dexamethasone Versus Local Infiltration Technique on Postoperative Nausea and Vomiting After Tonsillectomy in Children: A Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
Tonsillectomy is one of the most frequent surgical operations performed in children [1-4]. It is usually associated with postoperative nausea and vomiting (PONV) with an incidence ranging from 23% to 73% [2]. Dexamethasone has been shown to be effective in reducing PONV after tonsillectomy using standardized anesthetic technique [2, 5-7]. Previous studies utilizing a different technique, the pre-incision infiltration of local anesthesia, had shown to decrease post-tonsillectomy pain, reduce analgesic consumption and provide a rapid return to normal activity [8, 9]. Given the effectiveness of dexamethasone and the pre-incision infiltration anesthetic technique, it would be beneficial to compare the effect of each on PONV.
详细描述
Objective The purpose of this study is to compare the effect of dexamethasone versus the pre-incision infiltration of local anesthesia in pediatric tonsillectomy procedures. The primary outcome parameter of the study is the incidence of early PONV in the post-anesthesia care unit (PACU) and late PONV on the floor and 5 days after discharge. The secondary outcome is postoperative pain.
Methods Definitions Nausea is difficult to assess in children since they are not able to verbalize their feelings. Retching, which is the unproductive effort to vomit (no expulsion of gastric content), is considered an indicator of nausea. Therefore, for the purpose of this study, PONV is defined as vomiting and/or retching. Early PONV is defined as vomiting and/or retching in the PACU. Late PONV is defined as vomiting and/or retching on the floor and 5 days after discharge.
Study design The study will be conducted prospectively, using a randomized double-blinded placebo-controlled design. Thus, neither the surgeon nor the anesthesiologist will be aware of the injected solution content and they will not be involved in data collection. The patients and the residents who will collect the data will also be unaware of the patient's assigned group.
Sampling
Patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2015, whose ages range between 2 to 13 years will be included in the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for total or partial tonsillectomy with or without adenoidectomy
排除标准
- •Patients who received antiemetics, steroids, antihistaminics, or psychoactive drugs within 24 hours before surgery.
- •Patients who are suspected to have malignant neoplasm and signs of acute pharyngeal infection..
- •Patients who have asthma, diabetes mellitus, bleeding problems, and allergy towards bupivacaine.
研究组 & 干预措施
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: dexamethasone (Drug)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: General anesthesia (Drug)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: Tonsillectomy (Procedure)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: gastric content suction (Procedure)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: Tramadol hydrochloride (Drug)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: Propacetamol hydrochloride (Drug)
IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
干预措施: Paracetamol Suppository (Drug)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: Local anesthetic infiltration (Drug)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: General anesthesia (Drug)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: Tonsillectomy (Procedure)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: gastric content suction (Procedure)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: Tramadol hydrochloride (Drug)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: Propacetamol hydrochloride (Drug)
Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
干预措施: Paracetamol Suppository (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 5 postoperative days
incidence of early PONV in the post-anesthesia care unit (PACU) and late PONV on the floor and 5 days after discharge
次要结局
- Postoperative pain(5 postoperative days)
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital