Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in postoperative pain in children receiving tonsillectomy. However, fentanyl can cause postoperative nausea and vomiting (PONV), which is a main target side effect that medical staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may be different depending on the time of administration of fentanyl. However, the research design of patients enrolled in each study, such as the age, the name of the operation, and the method of anesthesia, is not identical. The aim of this study was to evaluate the efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective randomized controlled trial. Secondary outcomes include incidence and severity of emergence agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 3 to 7 years with ASA 1-II scheduled for tonsillectomy (or adenoidal tonsillectomy)
排除标准
- •History of developmental disorder, cognitive impairment, cerebral palsy
- •History of seizures(not simple febrile convulsions)
- •Upper respiratory infections
- •Structural airway disease predicting difficult airway
- •History of an adverse reaction, including allergic reactions to fentanyl
研究组 & 干预措施
fentanyl at 10-15 min before end of surgery
干预措施: fentanyl at 10-15 min before end of surgery (Drug)
fentanyl at end of surgery
干预措施: fentanyl at end of surgery (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Occurrence of nausea and vomiting- Described as yes/no (Observation of medical personnel or Subjective symptoms of the patient by the definition below) Nausea: "feeling of the urge to vomit" vomiting: "retching and any expulsion of liquid gastric contents"
次要结局
- FLACC score FLACC score (Face, Legs, Activity, Cry, Consolability scale): range 0-10. If the score is 4 or more, Pain control is considered necessary.(In 10-minute increments from immediately after entering PACU to departure)
- PAED scale score: *Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence.(In 10-minute increments from immediately(less than 3 min) after entering PACU to departure)
- five-step EA scale: *five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence.(In 10-minute increments from immediately(less than 3 min) after entering PACU to departure)
- anesthesia recovery time(up to 1 day after end of surgery)
- Occurrence of side effect(In 10-minute increments from immediately(less than 3 min) after entering PACU to departure)