Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.
Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.
详细描述
Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.
Data collection will be undertaken with the aid of experience research assistants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing Tonsillectomy and/or adenoidectomy
- •consented to undertake preop carbohydrate drink and follow up procedures
排除标准
- •Increased risk of aspiration or unable to swallow liquids
- •outside age range
- •non-consent to undertake treatment or follow up
研究组 & 干预措施
No Carbohydrate loading
Current standard of care
Carbohydrate loading
Patients to receive an oral preoperative carbohydrate drink
干预措施: Carbohydrate drink (Dietary Supplement)
结局指标
主要结局
Postoperative Pain Score
时间窗: day 1 postoperatively
Visual analogue scale (0-5)
次要结局
- Quality of sleep(Day 1 post operative)
- Patient and parent satisfaction(Day 1 postoperatively)
- Postoperative Nausea and Vomiting(4 hours postoperatively)
研究者
Jessica Gray
Principal Investigator Jessica Gray
IWK Health Centre