The Effect of Low Dose Nalbuphine or Ketamine in the Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children Undergoing Tonsillectomy With or Without Adenoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Emergence Agitation
研究概览
简要总结
The effect of low dose nalbuphine or ketamine in the prevention of emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy with or without adenoidectomy.
This randomized double-blind study was carried out at, Ain shams University Hospitals, from March 2021 to June 2021 on 90 patients after approval of the ethical committee.
详细描述
Emergence agitation (EA) in children is increased after sevoflurane anesthesia. Nalbuphine and midazolam have been used for prophylactic treatment with controversial results.
Patients and Methods:Totally, 90 children between 4 and 10 years of age and of American Society of Anesthesiologists I-II undergoing adenotonsillectomy under sevoflurane-based anesthesia were enrolled in the study. Children were randomly allocated to one of the three groups: Group N received nalbuphine 0.1 mg/kg, Group K received ketamine 0.25 mg /kg and Group S received the equivalent volume saline. The study medications was given after discontinuation of sevoflurane by the end of surgery. In the post anesthesia care unit emergence agitation was assessed with emergence agitation scale upon admission (T0), after 5 min (T5), 10 min (T10), 15 min (T15), 20 min (T20), 25 min (T25) and 30 min (T30).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients undergoing tonsillectomy with or without adenoidectomy
- •Age 4 - 10 years.
- •Sex: Both sexes
- •Patients with ASA classificaion I and II.
排除标准
- •Declining to give written informed consent.
- •History of allergy to the medications used in the study.
- •psychiatric disorder.
- •ASA classification III-V.
- •Fever ,cough , asthma or upper respiratory tract infection .
- •Anticipated difficult airway .
- •Hearing defect .
- •Neurological disorder.
- •Family history of malignant hyperthermia .
研究组 & 干预措施
Nalbuphine arm
0.1 mg /kg nalbuphine was given to 30 patients
干预措施: Nalbuphine Injection (Drug)
Ketamine arm
0.25 mg /kg ketamine was given to 30 patients
干预措施: Ketamine (Drug)
Saline arm
an equivalent volume of normal saline was given to 30 patients
干预措施: Saline (Drug)
结局指标
主要结局
Emergence Agitation
时间窗: At Time zero (The time of extubation)
5 step Emergence Agitation scale: describing change in mental status of the children during emergence from general anesthesia. The minimum value is 1 and maximum value is 5, and higher scores mean a better outcome. Score 1 Obtunded with no response to stimulation. Score 2 Asleep but responsive to movement or stimulation Score 3 Awake and responsive Score 4 Crying Score 5 Thrashing behaviour that requires restraint
次要结局
- Midazolam given for emergence agitation(30 minutes)
- Duration in PACU(45 minutes)
- Post-operative pain(30 minutes)
- Occurrence of laryngeal spasm(120 minutes)
- Time to hospital discharge.(6 hours)
- Occurrence of postoperative nausea and vomiting(120 minutes)
- Post-tonsillectomy bleeding.(120 minutes)
- Emergence Agitation at post anesthesia care unit(PACU)(At time of delivery to PACU)
研究者
Diaaeldein Mahmoud Haiba
Lecture of Anesthesia, ICU & Pain mangement faculty od medicine
Ain Shams University