Effect of Intravenous Nalbuphine on Emergence Agitation in Children Undergoing Repair of Rupture Globe
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesia
研究概览
简要总结
Our primary objective of this study is to compare the effect of administration of single dose of intravenous nalbuphine given with induction of anesthesia with intravenous nalbuphine given at the end of surgery on the incidence and severity of EA in children undergoing repair of rupture globe under general anesthesia.
The secondary outcomes will include FLACC score for postoperative pain assessment, hemodynamic variables, any complications as postoperative vomiting (POV) and sedation and parents' satisfaction score.
详细描述
Postoperative agitation, also referred to as emergence delirium is characterized by mental confusion, irritability, disorientation, inconsolable crying, and increased recovery time in the post anesthesia recovery room, increasing parents' concern and anxiety with respect to the clinical condition of their children . It can also lead to possible injury, damage to surgical dressings, lost intravenous catheters, disconnected cables and monitoring instruments, and source of dissatisfaction for parents, nurses, and others taking care of these children, and hence the children require extra nursing care and supplemental sedative and/or analgesic medications, which may delay patient discharge from hospital and are seven times more likely to have new-onset separation anxiety, apathy, and eating and sleep problems.
It is during the first 30 minutes after emergence that the greatest incidence of agitation is observed, and duration is generally limited and recovery occurs spontaneously. However, prolonged episodes of agitation lasting for up to 2 days have been described.
There is no definitive explanation for emergence agitation (EA). Many different causes have been suggested, such as rapid return of consciousness in an unfamiliar environment, the presence of pain (wounds, sore throat, and bladder distension), stressful induction, airway obstruction, a noisy environment, the duration of anesthesia, the child's personality, anesthetic premedication and the anesthetic technique used.
While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of EA in both adults and children . Children undergoing strabismus surgery under sevoflurane anesthesia often experience EA and postoperative vomiting (POV) .
Multiple medications including ketamine, propofol, clonidine, midazolam and fentanyl have been used effectively to prevent EA. However, these medications may increase sedation after anesthesia, cause slow awakening, and in some cases are associated with undesirable side effects, such as nausea and vomiting.
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
- Double (Participant, Investigator)
盲法说明
The trial will be planned that neither the doctors (investigators) nor the patients' guardians or even children themselves will be aware of the group allocation and timing of drug received
入排标准
- 年龄范围
- 3 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 3-8 years.
- •American Society of Anesthesiologists (ASA) physical status I-II scheduled to undergo repair of rupture globe.
- •Gender: both.
排除标准
- •Parent refusal.
- •History of developmental delay or mental retardation.
- •Known hypersensitivity to any drug used in this study.
- •Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders.
研究组 & 干预措施
Group A
40 randomly allocated Patients undergoing repair of rupture globe will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.
干预措施: IV nalbuphine 0.1 mg/kg with induction of anesthesia. (Drug)
Group B
40 randomly allocated Patients undergoing repair of rupture globe.will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
干预措施: IV nalbuphine 0.1 mg/kg at the end of surgery. (Drug)
结局指标
主要结局
The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesia
时间窗: at the first 30 minutes after surgery
the Incidence of Emergence Agitation will be evaluated using Aono's four-point scale. * minimum score: 1 * maximum score:4 Scores of one and two were considered as absence of EA, and scores of 3 and 4 were analyzed as presence of Emergence Agitation. 1. Calm 2. Not calm, but could be easily calmed 3. Moderately agitated or restless 4. Combative, excited, disoriente
次要结局
- postoperative vomiting(first 48 hours after surgery)
- Postoperative sedation(first 48 hours after surgery)
- The severity of Emergency Agitation(at the first 30 minutes after surgery)
- Postoperative FLACC Pain Score(first 24 hours after surgery)
研究者
Mohamed abdelhameed
M.M.B.CH& Resident Doctor
Assiut University
