Evaluation of the Effectiveness of Postoperative Pain Management in Pediatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- 0-59 months old age group pain intensity
研究概览
简要总结
This prospective, observational study evaluates the effectiveness of perioperative pain management strategies in pediatric patients undergoing elective surgical procedures. Pediatric patients aged 0-18 years were assessed using age-appropriate pain scales during the first postoperative hour to measure acute pain control. Pain scores, emergence delirium evaluations, and interventions administered during routine clinical care were recorded to determine the effectiveness of standard pain management approaches across age and surgical subgroups. This study will not interfere with the clinician's treatment methods in any way. The treatments applied and their frequency will be determined. The success of the procedures performed will also be evaluated.
详细描述
Pain management in pediatric patients remains challenging despite advances in medical techniques. Limited availability of centers performing high-risk pediatric operations, narrow therapeutic dose ranges of medications used in children, and limited clinical experience contribute to persistent difficulties in pain management. Evidence indicates that many surgical patients experience acute postoperative pain, and a significant proportion do not receive adequate pain relief. Inadequate pain control has been associated with prolonged hospital stay, respiratory complications, infection, and delayed recovery.
Improvements in outcomes observed with advances in pain management techniques highlight the importance of effective postoperative analgesia in pediatric populations. Adequate pain control in the early postoperative period reduces complications and may prevent the development of chronic pain syndromes.
This prospective, observational study is designed to evaluate postoperative pain management strategies applied in pediatric patients undergoing elective surgical procedures performed by the Pediatric Surgery Department. The study focuses on the frequency and effectiveness of multimodal analgesia and regional anesthesia techniques used in routine clinical practice.
Pain management strategies in pediatric patients are supported by international pain societies; however, challenges persist due to concerns regarding invasive procedures in younger children, limitations in opioid use, and variability in clinical experience. Regional anesthesia techniques, neuraxial analgesia, and patient-controlled analgesia are routinely applied in the institution, and evaluation of their clinical effectiveness and complication rates is intended to contribute to existing literature.
The study is conducted in the Pediatric Surgery Operating Rooms of Hacettepe University Hospital and includes pediatric patients undergoing elective procedures under general anesthesia. Patients are stratified into age groups to account for differences in pain perception and assessment ability. Early postoperative evaluation includes assessment of recovery status to minimize the influence of postoperative delirium on pain scoring.
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
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0-18 years operated on by the Pediatric Surgery Department,
- •Elective pediatric operations are performed under general anesthesia,
- •ASA I-III group patients,
排除标准
- •o Hemodynamically unstable patients. o ASA IV-VI group patients with life-threatening conditions. o Patients requiring emergency surgery.
- •0 Patients requiring emergency surgery. o Patients over 18 years of age,
- •Patients admitted under sedation,
- •Non-surgical diagnostic or minimally invasive procedures such as gastroscopy, colonoscopy, bronchoscopy, and direct laryngoscopy,
- •Non-surgical needle biopsies,
- •Catheter placement and removal procedures,
- •Pain management interventions for chronic pain patients (TENS, Acupuncture),
- •Neurological (patients with chronic analgesic syndrome, peripheral neuropathies, spinal cord injury, cerebral palsy, meningomyelocele, multiple sclerosis, and neurodegenerative diseases) and mental developmental delay (autism spectrum disorders, mental retardation, Down syndrome),
- •Patients being followed up and treated for psychiatric illnesses (depression, anxiety disorder, somatization disorder, conversion disorder, schizophrenia, and bipolar disorder),
- •Patients with chronic pain syndrome or neuropathic pain who are using continuous analgesics in the preoperative period. Patients with a history of drug and psychoactive substance use, patients who are intubated postoperatively or monitored under intensive sedation for a long period, patients who are hemodynamically unstable in the postoperative period, patients who develop serious postoperative complications (hemorrhage, sepsis, MOOS), patients who require repeat surgery during the postoperative follow-up period, patients for whom Informed Consent could not be obtained will be excluded from the study.
研究组 & 干预措施
0-18 years old pediatric patiens
The main aim of this study is to evaluate all pediatric patients undergoing elective surgery; to accurately assess pain, the age groups were divided into 3. 0-59 months old patients will be evaluated with the FLACC scale, 60-84 months old patients' pain will be determined with the Wong-Baker FACES Scale, and 85 months-18 years old patients' pain will be assessed with the VAS score.
结局指标
主要结局
0-59 months old age group pain intensity
时间窗: Within the first postoperative hour (0, 30, and 60 minutes after recovery).
Postoperative pain intensity was assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale in pediatric patients aged 0-59 months. Pain scores ≥4 indicate moderate pain requiring intervention, whereas scores ≥7 indicate severe pain. Pain scores below 4 are defined as successful pain management. Score on FLACC scale (range 0-10)
60- 84 months old age group pain intensity
时间窗: Within the first postoperative hour (0, 30, and 60 minutes after recovery).
Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale in pediatric patients aged 60-84 months. Pain scores ≥4 indicate moderate pain requiring intervention, whereas scores ≥7 indicate severe pain. Pain scores below 4 are defined as successful pain management. Score on Wong-Baker FACES scale (range 0-10)
85 months -18 year of age group pain intensity
时间窗: Within the first postoperative hour (0, 30, and 60 minutes after recovery).
Postoperative pain assessed using the VAS (Visual Analog Scale) in patients aged 85 months-18 years. Scores ≥4 indicate pain requiring intervention; scores ≥7 indicate severe pain. Scores \<4 indicate successful pain control. Unit of Measure: VAS score (0-10)
次要结局
- Need for rescue analgesia in the postoperative recovery unit(Within the first postoperative hour (0, 30, and 60 minutes after recovery).)
- Postoperative emergence delirium assessed by the PAED scale(Within the first postoperative hour (0, 30, and 60 minutes after recovery).)
研究者
Nuriye Sidar ARSLAN
MD
Hacettepe University