ACTRN12624000252516招募中4 期
A multicentre, double blinded randomised controlled trial investigating the efficacy of postoperative Melatonin in improving children’s sleep quality and recovery post-tonsillectomy.
Perth Children's Hospital0 个研究点目标入组 240 人开始时间: 2024年3月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 2 Years 至 16 Years（—）
- 性别
- All
入选标准
- •Children aged 2-16 years
- •Undergoing elective surgery under general anaesthetic for tonsillectomy +/- adenoidectomy +/- grommets or cautery inferior turbinates
- •Staying overnight in hospital
排除标准
- •Currently taking Melatonin
- •Known cardiovascular, respiratory or neurological disorders giving an American Society of Anaesthesiologists (ASA) physical status classification III or above status
- •Known hypersensitivity to the active substance or to any of the excipients listed
- •Language barriers impeding data collection
- •Department for Child Protection and Family Support is involved in their care
- •Planned admissions to the Paediatric Intensive Care Unit (PICU)
- •Any concern in the ability of the parents/guardian or child to appropriately adhere to the study protocol or any issues which, in the investigator’s opinion, would increase the risks of study participation to the child.
- •Day surgery tonsillectomy
研究者
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