跳至主要内容
临床试验/NCT06937684
NCT06937684已完成不适用

Oral Fluid Timing and Volume in Children Aged 1-8 Following Ambulatory Surgery: A Prospective Randomized Controlled Trial

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Tolerability of Early Oral Clear Fluid Intake in Children

研究概览

简要总结

This study investigates the safety and tolerability of early oral clear fluid intake in children aged 1-8 years undergoing elective outpatient non-gastrointestinal surgeries. Patients will be randomized to receive clear fluids either at 1 hour or 2 hours after general anesthesia. The goal is to determine whether earlier fluid intake increases the risk of postoperative vomiting (POV), or whether it can be safely tolerated in pediatric patients."

详细描述

This prospective, randomized controlled clinical trial aims to evaluate the safety and tolerability of early oral clear fluid intake in children aged 1 to 8 years undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia. Recent guidelines recommend reducing preoperative and postoperative fasting durations in children to enhance recovery and well-being. Early postoperative hydration has been associated with reduced opioid requirements, faster return to normal diet and ambulation, and shorter hospital stay, without increasing the risk of postoperative nausea and vomiting (PONV).

In this study, participants will be randomly assigned to one of two groups. Group E (early group) will receive up to 10 ml/kg of clear fluids (e.g., water, clear juice) one hour after the end of anesthesia, while Group T (traditional group) will receive the same amount two hours after anesthesia. Patients will be evaluated for readiness to drink based on recovery of consciousness, protective airway reflexes, and absence of nausea or vomiting. Fluid will be administered slowly and under strict supervision by experienced staff, with emergency equipment readily available.

The incidence of vomiting will be assessed using a modified 4-point scale. Additional outcome measures include tolerability of oral fluids, time to readiness for discharge, and incidence of delayed postoperative vomiting on postoperative days 1 and 3, assessed via phone interviews with caregivers. This study seeks to provide evidence-based guidance on the optimal timing and volume of clear fluid intake in pediatric patients following ambulatory minor surgical procedures, contributing to more flexible and patient-centered perioperative fasting protocols.

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
Single (Outcomes Assessor)

盲法说明

Only the outcomes assessor (the nurse responsible for evaluating postoperative vomiting) is blinded to the group assignments. No other study personnel, caregivers, or participants are masked in this trial.

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged between 1 and 8 years
  • •ASA Physical Status I or II
  • •Undergoing elective, outpatient, non-gastrointestinal surgery under general anesthesia
  • •Expected to be discharged on the same day
  • •Parent/guardian provides informed consent

排除标准

  • •Emergency surgeries
  • •History of gastrointestinal disorders
  • •History of aspiration or recurrent vomiting
  • •Children with neurodevelopmental delay
  • •Intraoperative complications requiring ICU admission
  • •Refusal of oral intake postoperatively

研究组 & 干预措施

Early Oral Intake Group (Group E)

Experimental

Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 1 hour after the completion of general anesthesia.

干预措施: Early Oral Fluid Intake (Behavioral)

Traditional Oral Intake Group (Group T)

Active Comparator

Patients in this group will receive a maximum of 10 ml/kg of clear fluids (e.g., water or clear fruit juice) starting at 2 hours after the completion of general anesthesia.

干预措施: Traditional Oral Fluid Intake (Behavioral)

结局指标

主要结局

Tolerability of Early Oral Clear Fluid Intake in Children

时间窗: From end of anesthesia to discharge (approximately 3-4 hours postoperative)

The number of pediatric participants who are able to tolerate clear oral fluids (up to 10 ml/kg) administered 1 hour after general anesthesia without experiencing vomiting, desaturation (SpO₂ \< 94%), or other adverse events. Tolerability is defined as successful ingestion of the planned fluid volume without signs of intolerance such as nausea, vomiting, or clinical deterioration.

次要结局

  • Total Volume of Oral Fluids Tolerated(Within 1 and 2 hours post-anesthesia)
  • Incidence of Postoperative Vomiting(From end of anesthesia to discharge (within approximately 4 hours))
  • Incidence of Postoperative Vomiting on Day 1 and Day 3(Postoperative day 1 and day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Early Oral Fluid Intake in Children After Day Surgery | 临床试验