Assessment of the Anaesthetic Potential of Akarkarabha & Lavanga Gel During Venipuncture in Neonates: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the assessment of "Pain Perception" experienced by the neonates during the venipuncture procedure.
研究概览
简要总结
Pain management in neonatal care is crucial for ensuring optimal outcomes in vulnerable newborns undergoing common procedures, such as venipuncture. While synthetic topical anesthetics are conventionally used, their potential side effects in neonates necessitate exploration of alternative approaches. This study pioneers the investigation of Ayurvedic herbal remedies, specifically Akarkarabha and Lavanga, known for their pain-relieving properties. The study aims to assess a novel formulation’s anesthetic potential in reducing pain during venipuncture in neonates, comparing it to conventional topical anesthetic. If successful, this Ayurveda-based intervention could revolutionize neonatal care, offering a safe alternative to conventional anesthetics and opening new avenues for research in herbal medicine and anesthesia. Previous work on Akarkarabha and Lavanga highlights their potential, but there is a lack of direct assessment in neonatal pain management, forming the basis for this pioneering study.
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
- •Neonates who have completed 48 hours of life uneventfully post birth at the time of enrolment.
- •Neonates with a minimum weight of 2500 grams at the time of procedure.
- •Neonates born at or after 37 completed weeks of gestation.
- •Neonates free from major congenital abnormalities and are not on any life-support.
- •Neonates scheduled to undergo venipuncture for medical evaluation.
排除标准
- •Neonates with skin lesions, or dermatological disorders.
- •Neonates receiving any concurrent systemic medications, other than the nutritional supplements.
- •Neonates born to mothers with compromised immune systems or mothers found positive for any communicable or infectious disease.
- •Neonates currently participating in other clinical trials.
结局指标
主要结局
The primary outcome of the study will be the assessment of "Pain Perception" experienced by the neonates during the venipuncture procedure.
时间窗: All assessments will be conducted at the following time points: | 1. Baseline, | 2. during venipuncture, and | 3. post-procedure (30 minutes after the venipuncture procedure).
The pain scores obtained from the scales will be the primary outcome to determine the anaesthetic potential of Akarkarabha and Lavanga topical gel in reducing pain perception during venipuncture in neonates.
时间窗: All assessments will be conducted at the following time points: | 1. Baseline, | 2. during venipuncture, and | 3. post-procedure (30 minutes after the venipuncture procedure).
次要结局
- As a secondary outcome, this study seeks to evaluate the incidence of sequelae or adverse events such as inflammation, erythema, oedema, alterations in skin integrity, localized infections, ecchymosis, delayed wound healing, & scar formation attributable to venipuncture within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site.(Within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site.)
研究者
DR CHHAVI ROSHA
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune