A Comparative Study To Assess The Analgesic Effect Of Rasna Syrup With 24% Sucrose In Procedural Pain In Neonates.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be the Reduction in pain
研究概览
简要总结
“Pain is valuable once you know you have learned from it, To cure sometimes, to relieve often, to comfort alwaysâ€, is a 15th century French description of the role of the physician. Although relief of pain is felt to be a cardinal principle of compassionate medicine, yet in practice, pain management is often an ignored aspect of neonatal care. `Prevention of pain among neonates is basic expectation of every parent. However, there are common misconceptions concerning newborn pain still existing in our society which include first, the false premise that newborns do not perceive pain. Secondly, that newborns do not remember pain and even if they do, it has no side effects. Thirdly that it is too dangerous to administer analgesia to newborns. Lack of adequate training of health care personnel, inability of the neonates to express themselves and fear of side effects of analgesics are some of the other reasons. This might be the reason that no available studies are there in literature which has shown use of any Ayurvedic preparation use for the prevention/management of pain in neonates.
Rasna– is being used in Ayurveda for relief of pain in adult population.So it can be tried in neonates as Rasna shows Vedanasthapak (Analgesic) activity in adults. Rasna has chemical constitute ‘diaryl heptanoids’ which exhibits prostaglandins biosynthesis inhibiting activities. Therefore, showing anti-inflammatory effect.
24% SUCROSE SOLUTION -Oral sucrose solution has been extensively studied and recommended for procedural pain relief in neonates including venepuncture. Sucrose work as relief of pain in neonates who are having painful procedure like venepuncture.
Till date many works done on Rasna and its Vedanasthapak (analgesic) effects but mainly concerned with adults.so this study will provide a detailed analysis and interpretation of Vedanasthapak (analgesic) properties of rasna on neonates
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 2.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Only full-term neonates who have completed 24 hours of age uneventfully.
- •2.Neonates delivered and admitted only at Bharti Ayurveda Hospital will be registered.
- •3.Neonates who require Venepuncture for investigations of any underline cause.
- •4.Neonates with stable vital signs like HR, RR, SPO
- •5.Neonates who are not on or not likely to be shifted on any life support system.
- •Neonates who had been fed 30 minutes prior to procedure.
排除标准
- •1.Neonates whose age less then twenty four hours.
- •2.Neonates who require life support.
- •3.Neonates with multiple congenital anomalies.
- •4.Neonates with unstable vitals.
- •5.Neonates who required active resuscitation.
- •7.Neonates with history of perinatal depression.
结局指标
主要结局
The primary endpoint of the study will be the Reduction in pain
时间窗: all the assessments will be conducted at the following time points: | 1.During venipuncture | 2.post procedure (30 minutes after the venipuncture procedure )
次要结局
- Secondary endpoint of the study will be Assessment of any allergic reaction or systemic(sequelae.)
研究者
Dr Shubham Kadam
Bharati Vidyapeeth Deemed to be University College of Ayurved