跳至主要内容
临床试验/NCT04859062
NCT04859062已完成不适用

The Effect of Applying Xylocaine Gel 2% to the Eye Preoperatively in Pediatrics Undergoing Squint Surgeries on Oculocardiac Reflex Intraoperatively and Postoperative Pain and Agitation: Cohort Study

Research Institute of Ophthalmology, Egypt1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)

研究概览

简要总结

Assessing the efficacy of lidocaine gel 2% application 10 minutes before surgery on post operative pain and the use of analgesics postoperatively

详细描述

After inhalational induction of anesthesia and applying the pulse oximeter to the patient's finger but and before cannulating or managing the patient's airway lidocaine gel 2% is efficiently applied to the surgical eye (to give more time for the gel to act without delaying the surgery) then cannulation and laryngeal mask inserted to maintain ventilation properly.

Applying lidocaine gel 2% should be filling the upper and lower 10 minute fornices before disinfecting the eye and starting the surgery

The primary outcome is assessing postoperative pain and need for postoperative systemic analgesia The secondary outcome is to monitor the oculocardiac reflex intraoperatively and the need for intraoperative atropine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 3 to 12 years
  • squint surgery

排除标准

  • below 2 years or more than 13

研究组 & 干预措施

control

Placebo Comparator

no lidocaine gel 2% is applied

干预措施: control group (Other)

lidocaine group

Experimental

the lidocaine gel 2% is applied to the operative eye preoperatively

干预措施: lidocaine gel 2% (Drug)

结局指标

主要结局

Postoperative pain after recovery in PACU using FLACC score (Face, Leg, Activity, Cry, Condolence)

时间窗: during surgery

FLACC (Face, legs, activity, cry, condolence): each parameter will take a score from 0 to 2 and the total of the 5 parameters is a score of pain ; 0 is for no pain and 10 is maximal pain

次要结局

  • oculocardiac reflex occurrence during muscle traction intraoperative(during surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Samir Salem

Researcher

Research Institute of Ophthalmology, Egypt

研究点 (1)

Loading locations...

相似试验