Dexmedetomidine versus ketamine by administration as nasal spray for sedation in children undergoing spine surgery

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/04/042249

Lead Sponsor: Ankur Luthra

Brief Summary: The Perioperative period can be veery traumatic time for young children undergoing any form of surgery. Anaesthesiologists strive to m minimise distress for children in the operating room and provide smooth induction of anaesthesia. Various premedications have been used to allay anxiety and facilitate smooth separation of children from their parents. Intranasal administration is easy and safe and reduces discomfort. Drugs like dexmedetomidine, ketamine, midazolam and fentanyl have been tried for sedation and anxiolysis. Atomisation of drug refers to making an aerosol, which gets better absorbed through the nasal mucosa and provides quite effective sedation. Since, there is discrepancy in the results of various studies on the superiority of one drug over the other via intranasal route by drops and there is no study comparing effectiveness of intranasal atomised dexmedetomidine versus ketamine for premedication in children, we hypothesised that intranasal atomised dexmedetomidine is equally effective to intranasal atomised ketamine as premedicant for anxiolytics and sedation in children of 1-10 years undergoing spinal dysraphism surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

Inclusion Criteria

64 ASA I and II children aged between 1-10years scheduled for spinal dysraphism surgery will be enrolled in this study.

Exclusion Criteria

Refusal of consent Known allergy to dexmedetomidine or ketamine ASA III or IV Children with cardiac anomalies Children with seizures Children with upper respiratory tract infection Children with liver disease Children with mental retardation Difficult cannulation (three or more attempts).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effectiveness of sedation between intranasal atomised dexmedetomidine versus intranasal atomised ketamine in pediatric population aged 1-10yr undergoing spinal dysraphism surgery by using University of Michigan Sedation Scale (UMSS).	At 30 minutes post drug administration via intranasal route.

Secondary Outcome Measures

Name	Time	Method
To compare the response to parental separation assessed by Parental Separation Anxiety Score (PSAS)	30 min after drug administration
To compare the time for post operative discharge from PACU by Modified Aldrete Scoring	At the end of PACU stay
To compare incidence of Emergence agitation assessed by using WATCHA Scale	At the end of surgery
To compare the successful rate of venous canulation assessed by Groningen Distress Rating Score	30 min after drug administration
To compare mask acceptance assessed by Mask Acceptance Scale	30 min after drug administration
To compare the hemodynamic changes (HR, MAP, SpO2) intraoperatively	35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 65 min, 70 min, 75 min, 80 min, 85 min and 90 min after drug administration

Trial Locations

Locations (1): PGIMER Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Ankur Luthra
Principal investigator
9868057732
zazzydude979@gmail.com