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临床试验/NCT03174678
NCT03174678已完成4 期

The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Ramsey Sedation Score

研究概览

简要总结

The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

详细描述

One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.

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
Single (Investigator)

盲法说明

Investigator

入排标准

年龄范围
2 Years 至 6 Years(Child)
接受健康志愿者

入选标准

  • The inclusion criteria is age between 2 to 6 years and American Society og Anesthesiology (ASA) grade 1.

排除标准

  • The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

研究组 & 干预措施

Control

Other

Apple juice

干预措施: apple juice (Other)

Dexmedetomidine

Experimental

Group administered 1µg/kg dexmedetomidine oral

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Ramsey Sedation Score

时间窗: 45 minutes after premedication

Sedation level

次要结局

  • Parental Separation Anxiety Score(preoperative)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SULTAN KELES

Assist. Prof.Dr.

Aydin Adnan Menderes University

研究点 (1)

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