Warm Humidified Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Post-operative Morphine equivalent analgesia use
研究概览
简要总结
In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the abdominal cavity for the creation a clear operating field, results in damage to the cavity lining, known as the peritoneum. This has been associated with negative effects on post-operative recovery. Adult studies using warm humidified insufflation gas have indicated possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased fogging of the laparoscopic camera lens, and reduced time to return to normal activities. Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in body core temperature (hypothermia). This has been established by trials in adult humans and animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation during laparoscopic removal of the appendix in children reduces intraoperative temperature variations, post-operative pain (indicated by morphine usage and pain scores), length of hospital stay and degree of camera lens fogging, and speed post-operative recovery compared to using cold dry gas insufflation.
详细描述
Study Aim/Question:
Does warm humidified carbon dioxide gas compared to cold dry gas for abdominal cavity insufflation during laparoscopic appendectomy in children reduce variations in intraoperative core body temperature, reduce post-operative pain, and improve post-operative recovery?
The Aim of this study is to investigate whether differences exist in the following outcomes:
- Intraoperative temperature variation;
- Need for post-operative opiate analgesia (primary outcome of the study);
- Post-operative pain scores;
- Length of hospital stay;
- Post-operative return to normal daily activities;
- Fogging of laparoscope lens; when warm humidified rather than cold dry gas is used for intra-abdominal insufflation during laparoscopic appendectomy for acute appendicitis in children.
Study Sample Size and Power Calculations:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/- appendicectomy.
排除标准
- •Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery
结局指标
主要结局
Post-operative Morphine equivalent analgesia use
时间窗: PACU, Post-operative 12 hours, Post-operative 24 hours, Post-operative 48 hours, Duration of hospital stay
Peri-operative Core Body Temperature Variation
时间窗: Intra-operative, Duration of stay in PACU
次要结局
- Pain scores measured by Visual Analogue Scale(Pre-operative baseline and Post-operative 2, 4, 6, 8, 10, 12, 24, 48 hours)
- Post-operative Return to Normal Daily Activities(Post-operative Day 10 Recovery Questionnaire)
- Severity of Post-operative Nausea and Vomiting as indicated by Antiemetic use(Post-operative Day 0, Day 1, Day 2, Day 3)
- Peri-operative Complications (operative and disease-related)(Up to 6 weeks post-operatively)
- Severity of Laparoscopic Camera Lens Fogging(Intra-operative)