A comparative study on the efficacy, onset of action and safety of 10 percent lignocaine spray versus EMLA cream in reducing pain during IV cannulation – a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain intensity assessed using Visual Analogue Scale (VAS) and Local Anesthetic Pain Assessment Questionnaire (LAPAQ)
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy, onset of action, and safety of 10% lignocaine spray versus EMLA cream in reducing pain associated with peripheral intravenous (IV) cannulation in adult patients. The primary hypothesis is that lignocaine spray provides comparable or superior analgesia with a faster onset than EMLA cream. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and the Local Anesthetic Pain Assessment Questionnaire (LAPAQ), a structured tool designed to evaluate the patient’s perception of pain relief, comfort, and satisfaction following local anesthetic application. Secondary outcomes include onset time, duration of anesthesia, success of first-attempt cannulation, adverse events, and patient satisfaction.
Note: Initial data from the first 30 participants may be analyzed and published as preliminary (pilot) findings to inform the full-scale study
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 60 years Either gender Requiring IV cannulation as part of routine care Intact skin over selected cannulation site on upper limb Provided written informed consent.
排除标准
- •Known allergy to local anesthetics History of methemoglobinemia or G6PD deficiency Presence of diabetes mellitus, peripheral vascular disease, or Raynaud’s disease Skin infection or ulceration at cannulation site Patients who are critically ill or unconscious Concurrent use of opioids or analgesics that interfere with pain assessment Pediatric patients.
结局指标
主要结局
Pain intensity assessed using Visual Analogue Scale (VAS) and Local Anesthetic Pain Assessment Questionnaire (LAPAQ)
时间窗: At 0 to 1 minute after IV cannulation
次要结局
- Time to onset of local anesthesia (in minutes)(At approximately 0 to 5 minutes after application of the drug, prior to IV cannulation)
- Duration of anesthetic effect(Measured from onset of numbness until return of normal sensation assessed at fixed intervals of 15 minutes 30 minutes 45 minutes & 60 minutes after intravenous cannulation)
- Success rate of first-attempt IV cannulation(At 0 minutes (immediately after first IV cannulation attempt))
- Incidence of adverse effects(At 15 minutes 30 minutes & 60 minutes after drug application)
- Patient satisfaction & perception of pain relief (using LAPAQ)(At 1 to 2 minutes after IV cannulation)
研究者
Raja Mydeen
SRM MCH and RC