| CTRI Number |
CTRI/2025/09/095383 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness of intranasal atomized dexmedetomidine versus ketamine as a premedication for providing sedation and anxiolysis in children undergoing adenotonsillectomy in general anaesthesia. |
|
Scientific Title of Study
|
A randomized comparative study of intranasal atomized dexmedetomidine versus ketamine as a premedication in children undergoing adenotonsillectomy in general anaesthesia at SMS Medical College Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
ENT OT Charak Bhawan Department of Anaesthesia SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
ENT OT Charak Bhawan Department of Anaesthesia SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahak Goyal |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College Jaipur |
| Address |
Department of Anaestheisa SMS Medical College Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413146822 |
| Fax |
|
| Email |
mahakgoyal1403@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Sawai Man Singh Medical College Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai Man Singh Medical College Jaipur |
| Address |
Department of Anaestheisa SMS Medical College Jaipur
302004
Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahak Goyal |
Sawai Man Singh Medical College and Attached Hospitals |
ENT OT Charak Bhawan Department of Anaestheisa SMS Medical College Jaipur
Jaipur
RAJASTHAN |
9413146822
mahakgoyal1403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee SMS Medical College Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J353||Hypertrophy of tonsils with hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal atomized dexmedetomidine (2.5 mcg per kg) |
Patients will be administered intranasal atomized dexmedetomidine (2.5 mcg per kg diluted to 2.6 mL with 0.9 percent saline) using intranasal mucosal atomization device as premedication 30 minutes before induction and level of sedation and anxiolysis is assessed.
|
| Comparator Agent |
Intranasal atomized ketamine (5mg per kg) |
Patients will be administered intranasal atomized ketamine (5mg per kg diluted to 2.6 mL with 0.9 percent saline) using intranasal mucosal atomization device as premedication 30 minutes before induction and level of sedation and anxiolysis is assessed.
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children scheduled for adenotonsillectomy under general anaesthesia.
2.Patients belonging to American Society of Anaesthesiologists (ASA) class I and II.
3.Patient’s parents willing to give informed written consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known allergies to dexmedetomidine or ketamine.
2.Patients with weight greater than 25 kg.
3.Patients with any congenital anomaly or syndrome.
4.Patients with history of seizures.
5.Patients with upper respiratory tract infection.
6.Patients with airway malformations or anticipated difficult airway.
7.Patients with intellectual disability.
8.Patients involved in any other study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine.
2.To assess and compare the ease of parental separation using Parental Separation Anxiety Score (PSAS) between the two groups
|
10 minutes, 20 minutes, 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare mask acceptance using Mask Acceptance Score (MAS) between the two groups .
2.To assess and compare the ease of venous cannulation using Groningen Distress Rating Scale (GDRS) between the two groups.
3.To assess and compare vital parameters like Heart Rate, blood pressure, oxygen saturation between the two groups.
4.To assess and compare adverse effects if any, between the two groups.
5.To assess and compare the incidence of emergence agitation using WATCHA Scale between the two groups.
|
10 minutes, 20 minutes, 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Paediatric patients present a unique set of challenges to the anaesthetist as preoperative anxiety in children leads to a difficulty in parental separation, i.v. cannulation, induction of anaesthesia, greater analgesic requirements and emergence agitation .Hence, the administration of balanced short-acting sedative agents with minimal risk of respiratory dysfunction is recommended under close monitoring of vitals. Dexmedetomidine is a selective alpha 2 agonist similar to clonidine, but with higher affinity to the alpha 2 receptor. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression and minimal effect on respiratory rate and tidal volume. Ketamine acts on the N methyl D aspartate receptor (NMDA R) producing a dissociative anesthesia. Ketamine is known to reduce central sensitization to pain, decrease overall opioid utilization, and produce effective sedation level. Oral administration has low bioavailability. Parenteral and intramuscular routes are invasive and painful. Intranasal application is a relatively non-invasive and easy route of administration which has the additional benefit of not requiring patient cooperation. With this background, we have planned this study to compare the efficacy of intranasal atomized dexmedetomidine versus ketamine as a premedication for anxiolysis and sedation in pediatric patients undergoing adenotonsillectomy in general anaesthesia. |