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临床试验/NCT06067854
NCT06067854已完成不适用

Perioperative Analgesia in Neonates Who Underwent Primary Cleft Lip Repair Surgery: Retrospective Study

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
1
主要终点
The cumulative consumption of opioids during surgery and 24 hours after surgery

研究概览

简要总结

In retrospective data search the investigators will identified the cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonate with cleft lips who underwent primary cleft lip repair surgery.

详细描述

The cumulative consumption of opioids during surgery and 24 hours after surgery in neonates with cleft lips who underwent primary cleft lip repair surgery is not known. Patients were divided into two groups according to the time period when they underwent surgery. Group 1 were neonates who underwent primary cleft lip repair surgery under general anaesthesia without regional anaesthesia - the time period before regional anesthesia is introduced into the standard procedure. Group 2 are newborns who underwent primary cleft lip repair surgery under general anaesthesia with regional anaesthesia. Group 1 underwent surgery in time period before regional anesthesia was introduced into the standard procedure. In this retrospective study, the anesthesiology perioperative data from January 2018 till December 2021 in the tertiary center of Pediatric anaesthesia will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • neonates with unilateral or bilateral cleft lip (U/BCL), all neonates with unilateral or bilateral cleft lip and alveolus (U/BCLA) or with unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent cleft lip repair surgery in the neonatal period
  • the study period (1/2018-12/2021)

排除标准

  • ● presence of coagulopathy
  • thrombocytopenia or thrombopathy
  • patients at risk of malignant hyperthermia
  • patients who were not neonates (older than 28 days)
  • patients who required postoperative mechanical ventilation

结局指标

主要结局

The cumulative consumption of opioids during surgery and 24 hours after surgery

时间窗: 24 hours after surgery

The cumulative consumption of opioid analgesics during surgery and 24 hours after surgery in neonates with regional block compared to neonates without regional anesthesia

次要结局

  • Complications(24 hours after surgery)
  • Oral intake(24 hours after surgery)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

Clinical Professor

Brno University Hospital

研究点 (1)

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