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临床试验/CTRI/2025/03/081819
CTRI/2025/03/081819尚未招募不适用

Investigating Optimal Approaches to Postoperative Nil by Mouth: A Preliminary Exploratory Study in Paediatric Patients Protocol

Institute of medical sciences, BHU1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年3月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
Incidence of POV in the immediate post operative period

研究概览

简要总结

Introduction: The literature extensively discusses preoperative fasting guidelines for pediatric patients(1). In contrast, postoperative Nil by Mouth (NBM) strategies in pediatric patients have received limited attention, baring a few articles (2,3). Practices regarding postoperative NBM vary, influenced by individual preferences and the nature of the surgical procedure, impacting patient safety   and recovery (2,3).

Major abdominal surgeries may necessitate a longer NBM period for the gastrointestinal tract to recover, while superficial surgeries, like circumcisions and hernia repairs, may have shorter NBM periods due to their minimal impact on the gastrointestinal system. The timing of introducing semisolid foods post-surgery varies among healthcare professionals, influenced by factors such as surgery type, patient condition, and institutional guidelines.

The European Society of Anaesthesiology recommends resuming liquid intake within 3 hours post-surgery in adults. Allowing normal food intake on the day of surgery in adults has shown positive effects, including a shorter time to bowel function resumption, reduced hospital stay, and fewer postoperative complications.

Postoperative fasting is crucial in pediatric daycare procedures, impacting discharge timing significantly. To address this, we are initiating a prospective randomized controlled trial in daycare pediatric surgeries. Our goal is to assess the feasibility of introducing a regimen involving clear fluids initially, followed by a transition to a soft diet based on the child’s recovery score, providing insights into determining the optimal postoperative Nil By Mouth (NBM) period for pediatric patients undergoing daycare surgeries.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Children aged 1 to 5 years undergoing daycare such as hernia, Opexy, circumcision Cystoscopy and Urethral Dilatation and Removal of moles, cysts, or other benign skin lesions.

排除标准

  • Surgeries with hospital stay,cavity invading surgeries, children prone to nausea and vomiting, and cases where parental consent is refused.

结局指标

主要结局

Incidence of POV in the immediate post operative period

时间窗: Incidence of POV in the immediate post operative period

次要结局

  • 1.time to first oral sip as per stewards score and time to first oral semisolid intake on demand(2. Pain score at 2, 4, 8, 12 and 24 hours using FLACC scale)

研究者

发起方
Institute of medical sciences, BHU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

AMRITA RATH

Institute of medical sciences, BHU

研究点 (1)

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