Effect of Fentanyl Given Approximately Ten Minutes to the End of Surgery on Emergence Delirium in Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital: A Randomized Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- The number of patients who develop emergence delirium in both arms
研究概览
简要总结
This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anaesthesiologists classes (ASA) 1 and 2 children.
- •ASA 1 - Normal healthy child scheduled for adeno-tonsilectomy.
- •ASA 2 - Child with mild systemic disease without functional limitations.
- •Children aged 1 to 12 years.
- •Children undergoing elective adeno-tonsilectomy.
- •Those children whose parents/guardians have given a written informed consent.
排除标准
- •Children with genetic syndromes.
- •Children with psychological/neurological behavioural disorders.
- •Children with allergies to Fentanyl.
- •Children with psychiatric disorders/ use of psychiatric medications.
- •Use of sedative medications one hour prior to surgery.
- •Children with developmental delay.
- •Children coming in as day case.
- •Children with airway problems not related to the surgery-sleep apnoea.
- •Children less than 1 year and those above 13 years.
研究组 & 干预措施
Fentanyl group
Fentanyl given at a dose of one micro gram per kilogram body weight
干预措施: Fentanyl (Drug)
normal saline group
placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.
干预措施: Normal saline (Drug)
结局指标
主要结局
The number of patients who develop emergence delirium in both arms
时间窗: 30 minutes
the number of patients who develop emergence delirium within 30 minutes after general anaesthesia will be assessed using Watcha scale indicated in the study questionnaire,
the local incidence of emergence delirium.
时间窗: 30 minutes
local incidence of emergence delirium will be determined by the percentage of those who develop emergence delirium in the placebo group within 30 minutes after general anesthesia as assessed by Watcha scale.
次要结局
- the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia.(30 minutes)
- duration of emergence time from general anaesthesia in minutes(30 minutes)
研究者
Dr. Kirwa Elisha kiprono
Dr.
University of Nairobi