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临床试验/CTRI/2024/07/069941
CTRI/2024/07/069941尚未招募不适用

A COMPARATIVE STUDY OF EFFECTIVENESS OF VAPOCOOLANT SPRAY AND EMLA CREAM IN REDUCING PAIN DURING INTRAVENOUS CANNULATION IN PAEDIATRIC POPULATION

HAREESH BABU1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年7月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
To compare efficacy of vapocoolant spray and EMLA cream in terms of pain score using Wong-Baker faces pain rating scale

研究概览

简要总结

Peripheral venous cannulation is one of the most common clinical interventions in health care system. This is a technique in which a cannula is placed inside a vein to provide direct access to circulating blood stream. Intravenous cannulation is a common painful procedure. No analgesics are routinely used. Needle related procedures induce anxiety, fear and distress especially in children. This could result in physiological, psychological, and emotional consequences such as increased pain sensitivity and inappropriate pain responses. Children may also show anticipatory anxiety which can generate physiological symptoms during needle related procedures, like vasovagal reactions, hypoxemia, tachycardia, and changes in hormonal levels. This can lead to needle phobia and even post-traumatic stress disorder. Therefore, the optimization of pain during these procedures is of pivotal importance in childhood.

 For pain reduction, some methods have been suggested and studied, including the use of topical anesthetics such as lignocaine, distraction techniques, producing vibration in the tissue of the injection site, imposing pressure, thermotherapy, and cooling the injection site. Some effective pharmacological methods for reducing patient’s pain are topical anesthesia techniques, including gels, ointments, patches, and topical anesthetic sprays, which can reduce the pain caused by intravenous cannulation.

EMLA cream is a topical anesthetic combination of two amide group of local anesthetics, lignocaine 2.5% and prilocaine 2.5%. EMLA cream is a 5% oil and water-based admixture containing 25 mg/ml of lignocaine and 25 mg/ml of prilocaine. Maximum dose of EMLA is 8 mg/kg. EMLA cream is applied onto non-injured skin with an occlusive adhesive bandage.

The local anaesthetics accumulate near pain receptors of the skin, and the neuronal membranes are stabilized by changing the depolarization of cell membranes to sodium ions and blocks the conduction of nerve impulses and can provide analgesia in the superficial layers of the skin to a depth of 5 mm.But its prolonged duration for the onset of peak action, that is 60-90 minutes, reduces its feasibility to be used as a topical anaesthetic for pain reduction during intravenous cannulation, especially in emergency situation.After skin disinfection, one gram EMLA cream will be applied in a thick layer over a prominent vein on the dorsum of the hand with an occlusive dressing for 60 minutes. After 60 minutes, occlusive dressing will be removed and IV cannulation is attempted.

Vapocoolant spray contains ethyl chloride acts as a cryoanalgesic which can be used prior to intravenous cannulation to attenuate pain. After applying vapocoolant spray, the skin temperature falls by less than 10°C compared to the body temperature after a 10 seconds of application.

Vapocoolant spray temporarily and rapidly interrupt pain transmission by lowering the skin surface temperature, reducing the sensitivity of pain receptors, and interfering with ion channel valves in pain transmission, causing topical skin anesthesia.So this can be used as an alternative analgesic used to induce rapid anaesthesia during vascular access in emergency conditions. After skin disinfection, vapocoolant spray will be applied at a distance of 10 cm for 10-15 seconds. Liquid on the skin will be allowed to evaporate before performing I.V cannulation.

PURPOSE : is to compare the efficacy of vapocoolant spray and EMLA cream to reduce pain during intravenous cannulation in children.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Children aged between 6-18 years undergoing elective surgeries requiring intravenous cannulation.

排除标准

  • Children undergoing emergency surgeries
  • Children with difficult cannulation
  • Children with failed cannulation in the designated site
  • Children with burns, broken or infected skin
  • History of allergy to local anaesthetics.

结局指标

主要结局

To compare efficacy of vapocoolant spray and EMLA cream in terms of pain score using Wong-Baker faces pain rating scale

时间窗: At 2 minutes

次要结局

  • To compare the ease of cannulation, hemodynamic changes, occurrence of adverse effects & cost analysis between two groups(1. Number of attempts- 0 minutes)

研究者

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

DR PRIYANKA P V

K. S HEGDE MEDICAL ACADEMY

研究点 (1)

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