Intranasal Versus Intravenous Fentanyl Effect on Oxidative Stress in Preterm Neonates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- measure MDA level as an oxidative stress marker.
研究概览
简要总结
To compare the effect of Intranasal versus Intravenous Fentanyl on oxidative stress by measuring MDA level just before and after 30 minutes from painful procedure and comparing the results.
详细描述
- Intra nasal fentanyl group: will receive intranasal fentanyl using nasal dose of INF is 1.5µg/kg/dose, and typically, one dose is given
• After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure) 2. Intravenous fentanyl group: will receive intravenous fentanyl(1 µg/kg/dose) and typically, one dose is given •After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure) Measure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure Monitor adverse events after fentanyl use as apnea (cessation of breathing for >20 s), bradycardia (heart rate < 100 beats/minute), desaturation (oxygen saturation < 80%), and chest wall rigidity associated with laryngospasm (Pacifici, 2015) for 60 min after IN fentanyl administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonates during endotracheal intubation
排除标准
- •o Contraindication of fentanyl use as hypersensitivity.
- •Contraindication of nasal administration of drugs as bilateral occluded nasal passage as choanal atresia and Epistaxis.
- •Surgical patients.
研究组 & 干预措施
intravenous fentanyl
Intravenous fentanyl group: will receive intravenous fentanyl(1 µg/kg/dose) and typically, one dose is givenMeasure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure
干预措施: fentanyl (Drug)
intranasal fentanyl
Intra nasal fentanyl group: will receive intranasal fentanyl (@fentanyl hamein 50mic/1ml, manufactured by sunny pharmaceutical) using nasal dose of INF is 1.5µg/kg/dose, and typically, one dose is given (Kaushal et al., 2020).
Measure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure
干预措施: fentanyl (Drug)
结局指标
主要结局
measure MDA level as an oxidative stress marker.
时间窗: just before fentanyl introduction and half hour after
次要结局
未报告次要终点