Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia (PEDLA-QOR)
Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial
研究概览
地位
详细说明
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.
Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.
The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Seher Orbay Yaşlı, Assistant Professor of Anesthe
- 电话号码:+905052401933
- 邮箱:sehersin81@hotmail.com
学习地点
-
-
Kayseri
-
Kayseri、Kayseri、土耳其(türkiye)、38039
- Erciyes University Faculty of Dentistry
-
接触:
- SEHER Orbay Yaşlı
- 电话号码:05052401933
- 邮箱:sehersin81@hotmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Children aged 7 to 12 years
- ASA physical status I or II
- Scheduled for ambulatory dental treatment under general anesthesia
- Ability to understand and respond to age-appropriate pain and recovery assessment tools
- Written informed consent obtained from a parent or legal guardian
- Child assent obtained when appropriate
Exclusion Criteria:
- Known allergy or contraindication to local anesthetic agents
- Developmental delay or cognitive impairment preventing assessment
- Autism spectrum disorder or severe behavioral disorder
- Neurological disease affecting behavior or consciousness
- Chronic analgesic or sedative medication use
- Severe hepatic, renal, cardiac, or respiratory disease
- Emergency dental procedure
- Need for postoperative hospital admission
- Inability to complete postoperative assessment tools
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Pre-emptive Local Anesthesia
Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia.
|
Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area.
The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group.
The total volume, total dose, dose per kilogram, and injection sites will be recorded.
|
|
无干预:No Local Anesthesia
Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia.
Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery
大体时间:PACU minutes 0, 5, 10, 15, and 30
|
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale.
The scale includes five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and consolability.
Each item is scored from 0 to 4, with a total score ranging from 0 to 20.
Higher scores indicate more severe emergence delirium symptoms.
Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.
|
PACU minutes 0, 5, 10, 15, and 30
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Pain Score
大体时间:PACU minutes 0, 5, 10, 15, and 30
|
Pain will be assessed using the Faces Pain Scale-Revised.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
|
PACU minutes 0, 5, 10, 15, and 30
|
|
Recovery Quality Before Discharge
大体时间:Before discharge on day of surgery
|
Recovery quality will be assessed using the QoR-15 Pictorial form before discharge.
The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery quality.
|
Before discharge on day of surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PEDGA-LA-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.