To see if nasal application of Dexmedetomidine will increase the pain free interval after caudal block in children undergoing infra-umbilical surgeries
- Registration Number
- CTRI/2021/09/036376
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
a)Age: 1-7 years b) ASA physical status grade I and II paediatric patients undergoing infra umbilical surgeries under General anaesthesia.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the role of instillation of intranasal dexmedetomidine on duration of postoperative analgesia after caudal block in children undergoing Infra-umbilical surgical procedures. From start of surgery to 6 hours post-operatively
- Secondary Outcome Measures
Name Time Method 1.Post-operative emergence delirium using Watcha score. 2.Post-operative sedation using Ramsey sedation score.
Trial Locations
- Locations (1)
AIIMS Delhi
🇮🇳South, DELHI, India
AIIMS Delhi🇮🇳South, DELHI, IndiaGanga PrasadPrincipal investigator9013232965drgpd@yahoo.com