Dexmeditomedine vs Morphine Infusion for pain relief in mechanically ventilated preterm neonates: A Randomized Control Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Time to achieve pain relief in the first 24 hours of commencing mechanical ventilation and hemodynamic stability during the study period.
研究概览
简要总结
Preterm neonates require care in the neonatal intensive care unit forvarious reasons. One of the common problems encountered in these neonates isrespiratory distress syndrome where the management could be either using CPAPor mechanical ventilation. Newborninfants, including those born extremely preterm, can perceive pain. The entireduration when the neonate is on the ventilator could be a stressful experiencefor the neonate. Painif unmanaged can have an immediate impact on hemodynamic and physiologic stabilityand altered stress hormone expression. There could also be long term effects onbrain growth, development, cognition, and motor components. Hence alleviatingpain is of prime importance. Various drugs have been used in intensive careunits to reduce pain in neonates. Current neonatal drug regimens used toachieve pain relief generally consist of combinations of benzodiazepines andopioids like morphine, fentanyl,midazolam . Though these drugs have proven efficacy assedatives and analgesics, they are often accompanied by a spectrum of sideeffects that might prolong the duration of ventilation and hospitalization.There is always a search for newer sedatives and analgesics which have feweradverse effects. Dexmedetomidine is one such drug that has been tried as it provides both sedation and analgesiawhen used alone, and has benzodiazepine and opioidâ€sparing properties when usedin combination with more conventional agents. The current study is being undertaken to knowthe efficacy of Dexmeditomedine versus morphine infusion in preterm ventilatedneonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 30.00 Day(s)(—)
- 性别
- All
入选标准
- •Preterm neonates between 28 and 36 weeks of gestation needing mechanical ventilation.
排除标准
- •Term babies Babies with congenital anomalies.
结局指标
主要结局
Time to achieve pain relief in the first 24 hours of commencing mechanical ventilation and hemodynamic stability during the study period.
时间窗: Pain to be assessed once in every 2 hours
次要结局
- hemodynamic instability in terms of bradycardia or hypotension needing inotropes.(Within 24 hours)
