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临床试验/CTRI/2022/06/043291
CTRI/2022/06/043291已完成不适用

The impact of early postoperative oral hydration in paediatric patients undergoing elective surgery after general anaesthesia. A randomized controlled trial.

Mridul Dhar1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年6月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
FLACC score

研究概览

简要总结

Justification for study- Pediatric patients are more prone for postoperative complications due to fear, hunger and thirst. They have very different physiological and psychological characteristics as compared to adults. Crying and agitation during postoperative period may cause airway spasm, severe hypoxemia leading to respiratory depression and apnoea, accidental falls and other adverse events. Therefore, it represents a safety concern in postoperative period and important for proper nursing of the child [1].

To prevent postoperative coughing, vomiting and aspiration risk, early feeding or oral hydration was not administered. But now it was found that early oral feeding and hydration to be beneficial and safe. The optimal time period for such administration of feeds and fluids is unclear, therefore, through this study we want to observe the impact of early oral feeding in children in postoperative period.

Hypothesis: Compared to standard delayed hydration, early hydration in paediatric patients undergoing elective surgery after general anaesthesia will  produce decrease in post operative FLACC score with no increase in incidence of complications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • ASA I-II status undergoing elective surgery general anaesthesia.

排除标准

  • Preoperative URTI,
  • Respiratory infections,
  • Facial, oropharangeal, thoracic, GI, neuro or laryngeal surgeries,
  • altered mental status,
  • Dysphagia,
  • Patients with untrustworthy psychiatric problems,
  • Patient refusal,
  • Child refusal to accept hydration at the time of intervention.

结局指标

主要结局

FLACC score

时间窗: 1. At arrival in PACU | 2. One hour after arrival in PACU

次要结局

  • 1.Complications(2.Parent satisfaction score (1- 10))

研究者

发起方
Mridul Dhar
申办方类型
Other [self]

研究点 (1)

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