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临床试验/CTRI/2021/09/036376
CTRI/2021/09/036376已完成不适用

Effect of Instillation of Intranasal Dexmedetomidine on the Duration of Caudal Analgesia in Paediatric Infra-Umbilical Surgeries

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
To evaluate the role of instillation of intranasal dexmedetomidine on duration of postoperative analgesia after caudal block in children undergoing Infra-umbilical surgical procedures.

研究概览

简要总结

Caudal block is the most common regional anaesthetic technique employedin paediatric patients. Major limitation tosingle shot caudal block is its short duration. Many adjuvants have been triedto prolong the duration of analgesia but each of them have their own sets ofside effects. Dexmedetomidine,a highly specific α2agonist has been tried as an adjuvant throughcaudal and intravenous routes. Intranasal route of dexmedetomidine with agood bioavailability and similar duration of action as other two routes isstill less explored. The current study is planned on fifty ASA 1,2 patientsbetween the ages of one to seven years undergoing infra-umbilical surgeries undergeneralanaesthesia. Upon fulfilling the inclusion and exclusioncriteria the recruited patients, after an in depth pre anaesthetic check-upwould be randomised into two groups where Group A (intervention group) wouldreceive caudal block with 0.25% Ropivacaine (1ml/kg body weight) followed byintranasal instillation of dexmedetomidine (1mcg/kg body weight) and Group B (controlgroup) would receive Caudal block with 0.25% Ropivacaine (1ml/kg body weight)followed by intranasal instillation of saline (similar volume todexmedetomidine as per body weight) after induction of general anaesthesia. Duringthe duration of surgery HeartRate, Mean Arterial Pressure, Oxygen saturation and M.A.C wouldbe monitored throughout and notedevery 5 min until the completion of surgery. Upon completion ofthe surgery the patient would be extubated and will be shifted to PACU, wherehe/she will be monitored for a period of 6 hours. Upon extubation using theWATCHA score the patient would be assessed for post-operative delirium. In PACUHeart rate, Respiratory rate, Sp02 willbe continuously monitored. Measurement of Pain and Sedation willbe carried out at following intervals in PACU - 0 mins, 30 mins, 1 hr, 2 hr, 4hr and 6 hr. Painwill be assessed using FLACC scale and Sedation will be assessed by Ramseysedation score. Supplementalanalgesia as fentanyl 0.5 mcg/kg will be given on self-reporting or whenFLACC score > 3*.* The patients will be observed for 10 min and thedose will be repeated if there is still pain. The same dosage will be repeatedin increments of 0.5mcg/kg till maximum of 2 mcg/hr. Total requirement offentanyl will be noted. Duration of analgesia taken as time period betweencompletion of caudal block and first analgesic administration will be measured.Any side effects like Bradycardia,Desaturation, PONV, excessive sedation, will be noted and treatedthroughout the period of study. Modified Aldrete score achieved at endof 6 hours will be noted where the study would conclude.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • a)Age: 1-7 years b) ASA physical status grade I and II paediatric patients undergoing infra umbilical surgeries under General anaesthesia.

排除标准

  • a)Parental or guardian refusal.
  • b)Allergy or hypersensitivity to any drugs.
  • c)Known hypersensitivity to dexmedetomidine.
  • d)Pre-existing cardiovascular, respiratory, cerebrovascular, neurological disease or coagulation disorders.

结局指标

主要结局

To evaluate the role of instillation of intranasal dexmedetomidine on duration of postoperative analgesia after caudal block in children undergoing Infra-umbilical surgical procedures.

时间窗: From start of surgery to 6 hours post-operatively

次要结局

  • 1.Post-operative emergence delirium using Watcha score.(2.Post-operative sedation using Ramsey sedation score.)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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