Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Incidence of Emergence Agitation in Post-anesthesia care unit
研究概览
简要总结
The goal of this clinical trial is to determine if deep touch pressure (DTP) can reduce emergence agitation (EA) in pediatric patients aged 3 to 10 years undergoing tonsillectomy and adenoidectomy under general anesthesia. The main questions it aims to answer are:
Does deep touch pressure (DTP) using a compression vest reduce the incidence of emergence agitation (EA) in the recovery room?
Does DTP reduce the severity of EA, as measured by the Pediatric Assessment of Emergence Delirium (PAED) scale?
Researchers will compare:
Intervention Group: Pediatric patients who receive DTP using the HUGgy compression vest during the recovery period.
Control Group: Pediatric patients who receive standard postoperative care without DTP.
Participants will:
Be randomly assigned to either the intervention group (DTP) or the control group.
Undergo standard general anesthesia for tonsillectomy and adenoidectomy.
Wear the HUGgy compression vest if assigned to the intervention group.
Be monitored for emergence agitation using the PAED scale and FLACC pain scale in the recovery room.
Receive rescue medication (nalbuphine) if severe EA occurs.
This study will help determine if DTP can be used as a safe and effective non-pharmacological method to reduce emergence agitation in pediatric patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.
排除标准
- •Emergency surgery.
- •Known neurological disorders (e.g., epilepsy, cerebral palsy).
- •Skin disorders or injuries on the chest or upper body that prevent safe use of the compression vest (HUGgy).
- •History of severe psychiatric disorders (e.g., autism spectrum disorder, severe anxiety disorder).
- •History of severe allergic reactions to anesthesia.
- •Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.
研究组 & 干预措施
Control group
DTP group
干预措施: HuGgy Compression vest (Device)
结局指标
主要结局
Incidence of Emergence Agitation in Post-anesthesia care unit
时间窗: Within 30 minutes of recovery room admission, at evaluable assessments
The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score 10 or greater within the first 30 minutes after admission to the post-anesthesia care unit
次要结局
- Maximum PAED Scale Score in Post-Anesthesia Care Unit(From PACU admission to discharge (up to 1 hour))
- Incidence of Severe Emergence Agitation (EA) in PACU(From PACU admission to discharge (up to 1 hour))
- Maximum FLACC Pain Score in PACU(From PACU admission to discharge (up to 1 hour))
- Duration of PACU Stay(From PACU admission to discharge (up to 1 hour))
- Use of Rescue Medication in PACU(From PACU admission to discharge (up to 1 hour))
- Compliance with Deep Touch Pressure (DTP) Intervention(From PACU admission to discharge (up to 1 hour))
研究者
Ji-Hyun Lee
Professor
Seoul National University Hospital