A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- child stress
研究概览
简要总结
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment
详细描述
This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:
- oral midazolam + oral ketamine + inhaled sevoflurane
- oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.
However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.
We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries
排除标准
- •Children presenting with at least one of the following:
- •airway obstruction and/or oral breathing;
- •recent use of systemic corticosteroids
- •needing less than two dental restorations;
- •previous dental sedation.
研究组 & 干预措施
Oral Midazolam
Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure
干预措施: Midazolam (Drug)
placebo
placebo oral syrup twenty minutes before starting the procedure
干预措施: Placebo (Drug)
结局指标
主要结局
child stress
时间窗: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion
level of salivary cortisol according to the ELISA
次要结局
- Child behaviour(every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes)
- sedative safety(during and twenty four hours after the procedure)
研究者
Heloisa de Sousa Gomes
Principal Investigator
Universidade Federal de Goias