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临床试验/NCT07021755
NCT07021755已完成不适用

Comparison Of The Effects Of Intranasal And Oral Midazolam Premedication On Sedation And Separation From Parents For Pediatric Patients

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
sedation

研究概览

简要总结

: The aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents.

详细描述

Patients meeting with anesthesiologists before surgery for assessment and administration of premedication is important in terms of reducing morbidity and mortality linked to surgery and anesthesia. A study reported that 75% of children experience anxiety before surgery. This anxiety and worry observed in the pediatric patient group may cause tachycardia, hypertension and tachypnea due to increased catecholamine levels in the body and may cause aggressive reactions that are difficult to control. Additionally, it may make control of postoperative pain more difficult .

Several drugs are used before anesthesia to resolve surgical anxiety in pediatric patients and facilitate problem-free transfer to the operating room.

Midazolam is a benzodiazepine group drug, commonly used for preoperative medication for a long time. Reasons for it being chosen for premedication are that it ensure sedation and anxiolysis, has rapid onset of effect, and is more amnesic than diazepam . Though there are many routes to administer the drug, IM and IV routes are painful and frightening for patients. The premedication administration route must be acceptable for the child and not be traumatic. As a result, generally oral and intranasal routes are chosen for sedation of pediatric patients.

The aim of this study was to compare the effects of intranasal and oral midazolam, administered for premedication to preschool children, on hemodynamic parameters, sedation level and separation from parents, and in terms of complications.

The study was planned as prospective, randomized and single-blind research. After receiving permission from the ethics committee of our hospital (Haseki Clinical Research Ethics Committee No: 28.05.2009/10), the study included a total of 60 children aged 2-6 years in ASA ( Physical Status Classification System) I-II group, with elective surgery planned under general anesthetic. . Patients were allocated to two equal groups with the closed envelope method (Group O, n=30, 0.5 mg/kg oral midazolam; Group N, n=30, 0.25 mg/kg intranasal midazolam). Midazolam was administered 20 minutes before the operation. Vital signs and sedation score levels were recorded every 5 minutes. At the end of the 20th minute, the separation from parents score was assessed and recorded. Assessments were completed by an anesthesiologist who did not know the method of administration for premedication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 2-6 years old
  • ASA I-II group
  • with elective surgery planned under general anesthetic.

排除标准

  • Patients allergic to midazolam
  • rhinorrhea
  • respiratory system dysfunction like nasal polyp
  • neurological or psychiatric disorder

结局指标

主要结局

sedation

时间窗: five minute

The level of sedation was monitored every 5 minutes with the Ramsey sedation scale. Sedation scores of 1 and 2 were inadequate, while sedation scores of 3 and 4 were accepted as satisfactory

次要结局

  • separation from parents(twenty minutes)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (2)

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