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临床试验/NCT07486427
NCT07486427已完成不适用

The Effect of Preoperative Child and Parental Anxiety on Emergence Agitation and Postoperative Pain in Children Undergoing Adenoidectomy and Tonsillectomy: a Prospective Observational Study

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年3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
99
试验地点
1
主要终点
Incidence and severity of emergence agitation

研究概览

简要总结

Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery

详细描述

Adenotonsillectomy, with or without adenoidectomy, is one of the most commonly performed surgical procedures worldwide in pediatric patients. Despite its widespread application, this surgery presents significant challenges for both surgeons and anesthesiologists due to the associated increased risks of morbidity and mortality. Safe administration of anesthesia is critical in avoiding complications and alleviating not only patient distress but also parental anxiety.

Preoperative anxiety in pediatric patients is influenced by several factors, including young age and parental concerns. Additionally, longer surgery durations (>30 minutes) and previous hospitalizations are known risk factors for heightened anxiety. Several previous studies have explored the relationship between parental stress levels and postoperative complications, including emergence agitation and pain. Research indicates a significant association between parental anxiety and postoperative behavioral disturbances in children.

The primary objective of this study is to evaluate the impact of preoperative parental anxiety and sociodemographic characteristics on the incidence and severity of emergence agitation in pediatric patients undergoing adenotonsillectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3-7 years who will undergo adenoidectomy, adenotonsillectomy or tonsillectomy surgery and their parents
  • Patients with ASA (American Society of Anesthesiologists) physical status I/II

排除标准

  • Patients with ASA score III and above
  • Conditions that prevent communication with the patient or parent (mental retardation, disability etc.)
  • Patients in whom routinely scheduled anesthetic and analgesic drugs cannot be administered due to allergy or contraindication
  • Patients who have previously received anesthesia or entered the operating room for a surgical procedure

结局指标

主要结局

Incidence and severity of emergence agitation

时间窗: From 1 to 30 minutes after extubation

The incidence and severity of emergence agitation (EA) were evaluated in the postoperative recovery room using the Watcha Behavior Scale (WBS). The Watcha Behavior Scale is a four-point scale used to assess the severity of emergence agitation in pediatric patients after anesthesia: (1) calm and cooperative; (2) mild restlessness but easily consoled; (3) agitated and inconsolable; and (4) severely agitated, thrashing, or combative.

次要结局

  • Parental preoperative anxiety(during the preoperative day and the day of surgery)
  • Preoperative anxiety in children(During the day of surgery)
  • Postoperative pain(During the first 30 minutes in the post-anesthesia care unit (PACU))

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deniz Karakaya

Professor

Ondokuz Mayıs University

研究点 (1)

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