Estimation of Analgetic Effect and Cooperability of Pediatric Patients During Application of Gaseous Mixture of Oxygen:Nitrogen Suboxide 50%:50% for Minimal Invasive Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score for children from 1 to 4 years
研究概览
简要总结
The goal of this observational study is to observe analgetic and anxiolytic effect of gass mixture of oxygen:nitrigen suboxide 50%:50% in pediatric patients sujected to minimal invasive procedures. The main question it aims to answer is: Does gass mixture of oxygen:nitrigen suboxide 50%:50% has effective anxyolitic and analgetic properties for minimal inavsive procedures in pediatric patients?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 Age 1-16 years 2 Veinpuncture 3 Arterial line placement 4 Nasogastric tube placement 5 Urinary catheter placement 6 Removal of thoracic drain 7 Skin suture
排除标准
- •Age <1 year or > 16 years
- •Pneumothorax
- •Pneumoperitoneum
- •Pneumocephalus
- •Otitis media
- •Obstructive lung disease
- •Upper airway infection
- •Methylenetetrahydrofolate reductase (MTHF) deficiency
- •Vitamin B12 deficiency
- •Megaloblastic anemia
研究组 & 干预措施
Peditric patients planned for minimal invasive procedure
Patients who will be sedated using oxygen:nitrogen suboxide 50%:50% gas mixture for minimal invasive procedure
结局指标
主要结局
Pain score for children from 1 to 4 years
时间窗: 5 minutes during the minimal invasive procedure
Pain assessed using pain scale: 1-4 years using FLAAC (Face, Leg, Activity, Cry and Consolability) pain scale. Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe
Pain score for children from 4 to 9 years.
时间窗: 5 minutes during the minimal invasive procedure
Pain assessed using pain scale: 4-9 years using Wong-Baker Faces Pain Rating Scale. Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe
Pain score for children from 9 to 16 years
时间窗: 5 minutes during the minimal invasive procedure
Pain assessed using pain scale: from 9-16 years using Numeric Rating Scale (NRS) Pain was categorized as: 0-no pain, 1-3 mild, 4-6 moderate and 7-10 severe.
次要结局
- anxiolytic effect(5 minutes during the minimal invasive procedure)
- hypotension(measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%)
- bradycardia(measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%)
- desaturation(measured 5 minutes after initiating application of gase mixture of oxygen:nitrogen oxide 50%:50%)
- level of sedation(Assessment will be made at the beginig of applicati)
研究者
Ana Mandras
Principal Investigator
Mother and Child Health Institute of Serbia Dr Vukan Cupic