Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Postoperative pain score on postoperative day one (abdominal pain)
研究概览
简要总结
The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prepped and consented for diagnostic laparoscopy for likely acute appendicitis
- •5 years or older
- •15 kg or more
- •Parents/legal custodian give consent, patient shows no signs of unwillingness to participate
- •Patient is hemodynamically stable
排除标准
- •Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis
- •Suspected perityphlitic abscess on preoperative ultrasound
- •Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties
- •Parents have inadequate knowledge of German language to understand Informed consent
- •Child has inadequate knowledge of German language to allow elicitation of Pain Scores
研究组 & 干预措施
Low pressure pneumoperitoneum
Use of low pressure pneumoperitoneum during laparoscopic appendectomy
干预措施: Laparoscopic appendectomy (Procedure)
Medium pressure pneumoperitoneum
Use of medium pressure pneumoperitoneum during laparoscopic appendectomy
干预措施: Laparoscopic appendectomy (Procedure)
结局指标
主要结局
Postoperative pain score on postoperative day one (abdominal pain)
时间窗: Postoperative day one.
Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
次要结局
- Analgesic use(Through study completion, an average of 3 days)
- Length of operation(Intraoperative)
- Length of stay(Through study completion, an average of 3 days)
- Postoperative pain scores during postoperative phase (abdominal pain)(Through study completion, an average of 3 days)
- Postoperative pain scores during postoperative phase (shoulder pain)(Through study completion, an average of 3 days)
- Intra- and postoperative complications(Through study completion, an average of 3 days)