跳至主要内容
临床试验/CTRI/2025/12/098440
CTRI/2025/12/098440尚未招募1/2 期

A Comparative Analysis of Pain Reduction in IV Cannulation Between Immediate and Delayed Application of Lignocaine as Local Anaesthetics

PURVI PATEL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Comparison of pain reduction after immediate and delayed application of local anesthetic during IV cannulation

研究概览

简要总结

Pediatric patients often experience anxiety and pain during medical procedures, such as intravenous cannula insertion, which can lead to distress, decreased compliance, and potential procedural delays. Despite the prevalence of such procedures, there is limited evidence on the most effective pain management strategies, particularly the use of local anesthetics. This study aims to address this gap through a randomized trial evaluating the efficacy of local anesthetics in reducing post-insertion pain. Effective pain management can improve patient comfort, mitigate long-term psychological impacts like needle phobia, enhance procedural compliance, and optimize healthcare resource utilization. By advancing evidence-based practices, this research supports the ethical imperative of ensuring pediatric well-being and promoting patient-centered care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Age Range: Children aged 8 to 18 years old.
  • Consent: Written informed consent from parents or guardians and assent from children aged 7 and above.
  • Procedure: Children scheduled for elective intravenous cannula insertion as part of medical treatment or diagnostic procedures.
  • Health Status: ASA (American Society of Anesthesiologists) physical status classification I or II.
  • Previous Experience: Children with no previous negative experience with IV cannulation to avoid psychological biases.
  • Communication: Ability to understand and communicate pain levels using age-appropriate pain scales.
  • Stable Condition: Children who are in a stable medical condition and not in acute distress.

排除标准

  • Allergies: Known allergy or sensitivity to local anesthetics (e.g., lidocaine, prilocaine).
  • Skin Conditions: Presence of skin infections, dermatitis, or other skin conditions at the site of cannula insertion.
  • Medical Conditions: Children with chronic pain conditions or on regular pain medication.
  • Cooperation: Children who are unable to cooperate or follow instructions due to developmental delays, severe anxiety, or other behavioral disorders.
  • Recent Procedures: Children who have undergone IV cannulation within the past month to avoid sensitization or tolerance.
  • Weight: Extreme underweight or overweight children where standard dosing of local anesthetic may not apply appropriately.
  • Parental Refusal: Parents or guardians who refuse the use of local anesthetic for the procedure.
  • Language Barrier: Families unable to communicate effectively in the language used for the study without the aid of an interpreter.

结局指标

主要结局

Comparison of pain reduction after immediate and delayed application of local anesthetic during IV cannulation

时间窗: 1 year

次要结局

  • Onset and duration of pain relief after application of local anesthetic(1 year)

研究者

发起方
PURVI PATEL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

PURVI PATEL

Pramukhswami medical college, Karamsad

研究点 (1)

Loading locations...

相似试验