Comparing dexmedtomidine vs fentanyl infusion in effective sedation in preterm neonates- a randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cumulative Duration of Sedation
研究概览
简要总结
4. AIMS & OBJECTIVE:-
a. AIM:- Comparing Dexmedtomidine vs Fentanyl infusion in Effective sedation in Preterm Neonates-A Randomized Control Trial
Consent-
Parents or legally acceptable representative (LAR) of newborns meeting eligibility criteria will approached for informed consent. An information sheet providing the details of the study will be provided to the parents/LAR Parents are free not to participate, or to withdraw their child from the study at any point of time and no coercion will be involved.
b. OBJECTIVE:-
PRIMARY Cumulative Durationof Sedation
SECONDARY 1. Duration of Respiratory support
-
Late onset sepsis
-
Requiring Adjunctive sedative medication
-
With drawl symptoms prevalence/duration.
-
Sedative medication stopped prematurely due to side effects
-
Days to Reach full feed
5. MATERIALS AND METHOD
a. TYPE OF STUDY- RANDOMISED CONTROL TRIAL
b. STUDY AREA- Neonatal intensive care unit, Neotia getwel multispeciality hospital
c. STUDY PERIOD – 1 Year
d. STUDY POPULATION-
INCLUSION : preterm (28-37 weeks),post natal age< 28 days
Requiring Respiratory support
Requiring pain management as per Pain score (NPASS) >3
EXCLUSION : Severe Neurological Issue
Congenital Anomaly
Any contraindication for starting pain pharmacotherapy (No intestinal peristaltic sounds, Hypotension ,Bradycardia)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •preterm (28-37 weeks),post natal age less than 28 days Requiring Respiratory support Requiring pain management with pharmacotherapy as per Pain score (NPASS) more than 3.
排除标准
- •Severe Neurological Issue Congenital Anomaly Any contraindication for starting pain pharmacotherapy (No intestinal peristaltic sounds, Hypotension ,Bradycardia).
结局指标
主要结局
Cumulative Duration of Sedation
时间窗: at 1 wk after randomization
次要结局
- Duration of Respiratory support(at 1 wk and 2wk after randomization)
- Late onset sepsis(any time prior to discharge)
- Requiring Adjunctive sedative medication(any time prior to discharge)
- With drawl symptoms(any time prior to discharge)
- Sedative medication stopped prematurely due to side effects(any time prior to discharge)
- Days to Reach full feed(at 1 wk and 2 wk and 3 wk)
研究者
Dr Aritra Ray
Neotia Getwel Healthcare Centre