Comparison of 10 percent Lidocaine Spray versus 2.5 percent Lidocaine and 2.5 percent Prilocaine i.e.EMLA Cream for Attenuating Pain from Peripheral Venous Cannulation in Children: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Pain during intravenous cannulation . Visual analogue scale score measured at the time of cannulation
研究概览
简要总结
This study compares 10 percent lidocaine spray with EMLA cream made of 2.5 percent lidocaine and 2.5 percent prilocaine for reducing pain during intravenous cannulation in children aged 5 to 14 years undergoing elective surgeries. A total of 126 children will be randomly divided into two equal groups. One group will receive lidocaine spray and the other will receive EMLA cream before cannulation. The primary outcome is pain score measured using the visual analogue scale during cannulation. Secondary outcomes include heart rate changes before during and after cannulation, ease of cannulation, and local site reactions such as redness swelling and hardening at 20, 40 and 60 minutes after cannulation. The purpose of the study is to find out which topical anesthetic provides faster onset, better safety and more effective pain relief for children undergoing intravenous cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 5 and 14 years undergoing elective procedures requiring anaesthesia American society of Anaesthesiologists (ASA) grade 1 and 2.
排除标准
- •Children with difficult IV cannulation Emergency surgeries with burns, broken or infected skin Intellectual disabilities BMI above 85th percentile.
结局指标
主要结局
Pain during intravenous cannulation . Visual analogue scale score measured at the time of cannulation
时间窗: Pain score at the time of baseline - during the time of intravenous cannulation | and hemodynamic parameters measured five minutes before ,at the time of cannulation and five minutes after cannulation
Hemodynamic parameters like heart rate and oxygen saturation is measured
时间窗: Pain score at the time of baseline - during the time of intravenous cannulation | and hemodynamic parameters measured five minutes before ,at the time of cannulation and five minutes after cannulation
次要结局
- Heart rate changes before, during, after), ease of cannulation, and local side effects(Twenty , forty and sixty minutes after the cannulation)
研究者
Shenaz Banu
Sri Venkateshwaraa Medical College Hospital and Research Centre