Investigation of the Incidence of Postoperative Chronic Pain in Children Aged 8 to 17 Years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- The Numeric Rating Scale (NRS)
研究概览
简要总结
The objective of this study is to assess the incidence of chronic postoperative pain in pediatric patients aged 8 to 17 years following surgical procedures. Furthermore, it seeks to identify potential risk factors contributing to the development of such pain and to evaluate its long-term implications.
详细描述
Children aged 8 to 17 years who have undergone surgery at Kocaeli University Faculty of Medicine and voluntarily agree to participate in the study for a duration of six months will be included.
Children with speech or communication disorders, those who experience postoperative complications, those with psychiatric or neurological conditions, or those with a history of chronic or long-term pain will be excluded from the study.
The participants and their families will be informed about the purpose of the study, the procedures to be followed, the duration of the study, and any potential risks. Written informed consent will be obtained from the parents of all participants. In addition, participants will be asked to complete the informed consent form.
Each participant will be asked to allocate approximately 15 minutes to complete the questionnaires and assessment tools used in the study.
Data such as age, gender, weight, height, ASA score, medical and surgical history, type of surgery, incision size, surgical site, duration of surgery, type of anesthesia and analgesia used, medication doses, intraoperative anesthesia records, length of hospital stay, and any surgical complications will be recorded.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation
- •Undergoing a surgical procedure under anesthesia at our hospital
- •Availability of complete patient data for a 6-month postoperative follow-up period
排除标准
- •Presence of speech or communication disorders
- •Development of postoperative complications
- •Undergoing any additional surgical procedure for any reason during the 6 months follow-up period
- •Having diagnosed psychiatric or neurological disorders
- •Having a pre-existing history of chronic or long-term pain
结局指标
主要结局
The Numeric Rating Scale (NRS)
时间窗: Six months
The Numeric Rating Scale (NRS) is a commonly used pain assessment tool that consists of a numerical scale ranging from 0 to 10. On this scale, 0 indicates no pain, 1 to 3 represents mild pain, 4 to 6 indicates moderate pain, 7 to 9 reflects severe pain, and 10 corresponds to unbearable pain. Patients are asked to select the number that best describes the intensity of pain they are experiencing.
次要结局
- The Pediatric Quality of Life Inventory (PedsQL)(Six months)
研究者
Onur ERDEM
Research Assistant Doctor
Kocaeli University