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临床试验/CTRI/2025/10/095952
CTRI/2025/10/095952尚未招募Unknown

Efficacy of cryo-vibro-analgesia on propofol injection pain in paediatric patients undergoing surgery under general anaesthesia: A randomised control study

Dr Zainab Ahmad1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Pain score on composite behavioral scale.

研究概览

简要总结

Propofol is the most common intravenous anesthetic drug used for induction and maintenance of general anesthesia owing to its rapid onset, short duration and favourable safety profile. However, the incidence of pain following propofol injection is seen in approximately 70% patients. The methods of pain relief during propofol injection include pharmacological and non-pharmacological means. The most accepted technique is administration of lignocaine either mixed in the syringe or administered prior to injection of propofol. This study aims to evaluate effect of cryo-vibro-analgesia technique using Buzzy device on pain associated with propofol injection in children (5-12years) undergoing surgery under general anaesthesia. Though multiple studies have evidenced the role of Buzzy device and its cryo-vibro-analgesia on mitigation of pain in vaccinations and insertion of IV cannula, there is no study on its effectiveness in reducing propofol injection pain in children. In this study after taking written informed consent, patients will be randomized into either treatment or control group. In treatment group Buzzy device will be fixed 5cm above the cannulation site along with frozen wings and turned on for 1min before propofol injection. In control group Buzzy device will be applied similarly with unfrozen wings and not switched on. During the propofol injection, pain will be assessed and graded using a composite behavioral scale. Following induction the study will be terminated and monitoring will continue for 24 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA I, II Consenting parents or guardians 5-12 years old patients posted for elective non cardiac surgery.
  • Should be alert enough to respond and provide feedback for the procedure.
  • Should have availability of upper limb (venous access) for the procedure.
  • Planned for IV induction of anaesthesia.
  • Pre-existing free flowing cannula.

排除标准

  • On Sedation IV line on lower limb On mechanical ventilation Peripheral Vascular Disease, pre-existing chronic pain/neuropathy Significant edema or Thrombophlebitis in the limb Modified Yale Preoperative Anxiety Scale (mYPAS) score more than 30.

结局指标

主要结局

Pain score on composite behavioral scale.

时间窗: During or immediately after propofol injection

次要结局

  • To evaluate the incidence of pain experienced during or immediately after propofol injection in pediatric patients (5–12 years) using a combined cold and vibration device (cryo-vibro-analgesia with Buzzy® device) as compared to the lignocaine-propofol admixture.(During or immediately after propofol injection.)
  • To evaluate the tolerability of the Buzzy device in pediatric patients.(During propofol injection.)
  • To evaluate provider-reported ease of use.(After propofol injection)
  • To evaluate acceptability of device in pediatric patients(On POD 1)

研究者

发起方
Dr Zainab Ahmad
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Khyati Jain

AIIMS BHOPAL

研究点 (1)

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