Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of any perioperative respiratory adverse events (PRAEs)
研究概览
简要总结
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
详细描述
Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.
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)
盲法说明
The drug will be prepared by an anesthesia nurse who will not be involved in the study. The active drug will be administered by a fully trained anesthesiologist and Clear definitions of the respiratory adverse events will be provided to the involved anesthetist. All researchers directly involved in the study will be blinded to the drug which will be administered
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children both sexes male and female.
- •Age from 3 to 12 years old.
- •ASA grade I, II.
- •undergoing elective AT procedures.
排除标准
- •Congenital heart diseases (cyanotic and a cyanotic).
- •Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
- •Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
- •Recent upper respiratory tract infection (less than two weeks).
- •Neuromuscular diseases including cerebral palsy and epilepsy.
研究组 & 干预措施
(Group M)
The midazolam group will receive intranasal midazolam (0.1 mg/kg)
干预措施: The midazolam group (Drug)
(Group MK)
Midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)
干预措施: The midazolam ketamine group (Drug)
结局指标
主要结局
The incidence of any perioperative respiratory adverse events (PRAEs)
时间窗: 8 hours
the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.
次要结局
- Postoperative pain score(8 hours)
- Sedation success rate(8 hours)
- Postoperative emergence delirium(8 hours)
研究者
Khaled Abdelfattah Abdallah Sarhan
principal investigator, Asst. professor of anesthesia, Cairo university
Kasr El Aini Hospital