Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Postoperative vomiting
研究概览
简要总结
The majority of pediatric surgery takes place in an outpatient basis. The occurrence of postoperative vomiting can lead to a delay in hospital discharge. However, the use of postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects and also raises the final costs of the surgical procedure. The Objective our study is Compare the incidence of postoperative vomiting between children who received dexamethasone, dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting prophylaxis in children submitted to general anesthesia. Data analysis will be used is Fisher's exact test for the categorical variables and the Anova test for numerical variables as they presented Gaussian variation. The study used a significance level of 5%.
详细描述
The investigators know that a large number of pediatric surgeries are performed on an outpatient basis and the occurrence of nausea and vomiting after surgery can lead to delayed discharge and increased hospital costs. Based on this fact, the investigators find it relevant to determine the incidence of postoperative vomiting in pediatric surgery patients to assess the need for antiemetic prophylaxis in this study population being developed in the surgical ward of the Hospital das Clinicas - Federal University of Pernambuco (HC-UFPE ).
The study will be conducted from March 2011 to September 2011.Pacientes pediatric ASA I and II underwent surgery in the pediatric surgical ward of the HC-UFPE.
The sample size calculation was performed in the program StatCalc Epi-Info 6.04d, based on data from relevant literature and determined the presence of 44 patients in each of the three groups, totaling 132 patients in the study.
Patients will be recruited in the preparation room anesthetic in surgical clinics of the Hospital for three shifts of existing pediatric surgery. After evaluation of each patient and then filled the criteria of inclusion and exclusion, those responsible will be informed about the procedures being undertaken and the possible consequences of their participation in research.
Only after signing an informed consent by the person responsible will be held the allocation of patients into three groups, after opening the sealed envelope containing the selected group for that participant. These envelopes are previously prepared by a person outside the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •Patients aged between 1 and 10 years old
- •Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis
排除标准
- •Officials who refused to sign the consent form
- •ASA ≥ III
- •History of allergy to dexamethasone and/or ondansetron
- •Patients taking opioids preoperatively
- •Patients using antiemetic drugs preoperatively
- •Patients with vomiting preoperatively
研究组 & 干预措施
Dexamethasone
Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure.
干预措施: Dexamethasone (Drug)
Dexamethasone and ondasetron
Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling) and ondansetron (0.1 mg / kg dose of 4mg ceiling)at the beginning of the procedure.
干预措施: Dexamethasone and ondasetron (Drug)
结局指标
主要结局
Postoperative vomiting
时间窗: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone
Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.
次要结局
- delayed discharge(In-room post-anesthesia recovery)