“Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in pediatric undergoing surgical procedure.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maharani laxmi bai medical college jhansi
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- To compare the degree of sedation provided by the administration of intranasal atomized dexmedetomidine and ketamine in both group.
Overview
Brief Summary
Patients were randomised into two groups using random allocation software. Patients assigned to Group I received intranasal atomised dexmedetomidine 2.5mg/kg , 30 min before induction. Patients in Group II received intranasal atomised ketamine 5mg/kg 30 min before induction.
Both the study drugs were diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume was added to account for the dead space of the atomiser.
A detailed pre-anaesthetic evaluation was done and adequate fasting as per standard guidelines was ensured.
The calculated dose of the study drugs was administered using a 2 ml syringe and the mucosal atomisation device.
We administered half of the dose in one nostril and the other half in the other nostril in an upward and outward direction with the child in the supine position.
Sedation was assessed at 10, 20 and 30 min in both groups using the UMSS which is a simple, valid and reliable tool that facilitates rapid assessment and documentation of depth of sedation in children and a score of 2 was considered satisfactory.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent,ASA 1and 2 patients,Age between 1-10years,Normal coagulation status.
Exclusion Criteria
- •Not given written informed consent,ASA status 3 and 4 ,Abnormal coagulation,Hemodynamically unstable ,Hematological,cardiovascular disorder ,allergy or contraindication of study drugs,history of seizure,upper respiratory tract infection,Arnold chiari malformation,Active liver disease,Difficult airway,Intellectual disabiltiy.
Outcomes
Primary Outcomes
To compare the degree of sedation provided by the administration of intranasal atomized dexmedetomidine and ketamine in both group.
Time Frame: 3 months
Secondary Outcomes
- To compare the ease of parental separation and venous cannulation in both groups along with the degree of successful mask acceptance , perioperative vital parameter, along with incidence of emergency agitation.(3 months)
Investigators
Dr Shubam Achari
Maharani laxmi bai medical college jhansi