| CTRI Number |
CTRI/2024/11/077125 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ketodex (Ketamine+dexmedetomidine) versus midazolam as nasal spray for sedation in children undergoing spine surgery |
|
Scientific Title of Study
|
Comparison of the efficacy of Intranasal Atomised Ketodex versus Intranasal Atomised Midazolam as a Premedicant for anxiolysis and sedation in children aged 1 to 10 years undergoing spinal dysraphism surgery- A randomized double-blinded controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| INT/IEC/2024/SPL-1169 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Luthra |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate institute of Medical Education and Research, Chandigarh |
| Address |
Room No. 1, B-Block, 5th floor, Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9868057732 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankur Luthra |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate institute of Medical Education and Research, Chandigarh |
| Address |
Room No. 1, B-Block, Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9868057732 |
| Fax |
|
| Email |
zazzydude979@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shruti Bhatt |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate institute of Medical Education and Research, Chandigarh |
| Address |
Nehru Hospital, 4th floor, Block A, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
7251812716 |
| Fax |
|
| Email |
shruti12bhatt@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Ankur Luthra |
| Address |
Department of Anaesthesia and intensive Care, Nehru Hospital, PGIMER, Sector 12, Chandigarh - 160012 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ankur Luthra |
PGIMER Chandigarh |
Main OT complex,Department of Anaesthesia and Intensive care, 4th Floor, A-Block, Nehru Hospital
Chandigarh
CHANDIGARH Chandigarh CHANDIGARH |
9868057732
zazzydude979@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients will be receiving Intranasal atomised ketodex (Ketamine 3mg/kg + Dexmed 1 mics/kg) 30 minutes before induction. |
A calculated dose of ketamine 3 mg/kg and 1 mics/kg dexmedetomidine will be diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume will be taken for dead space of atomiser. Half of this dose will be administered in one nostril and other half in the other nostril in upward and outward direction with child in supine position 30 minutes before induction once only. |
| Comparator Agent |
Patients will be receiving Intranasal atomised midazolam (0.4 mg/kg) 30 minutes before induction. |
The calculated dose of 0.4 mg/kg midazolam will be diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume will be added for dead space of atomiser. Half of the dose will be administered in one nostril and the other half in the other nostril in an upward and outward direction with the child in the supine position |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
70 ASA I and II children aged between 1-10 years who were scheduled for spinal dysraphism surgery will be enrolled in this study. |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the effectiveness of sedation between intranasal atomised ketodex versus midazolam in children aged 1 to 10 years undergoing spinal dysraphism surgery by University of Michigan Sedation Scale (UMSS). |
30 minutes after drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the response to parental separation assessed by Parental Separation Anxiety Score (PSAS) |
30 min after drug administration |
| To compare the successful rate of venous canulation assessed by the Groningen Distress Rating Score (GDRS) |
30 min after drug administration |
| To compare mask acceptance assessed by the Mask Acceptance Scale (MAS) |
30 min after drug administration |
| To compare the hemodynamic changes (HR, MAP, SpO2) |
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 |
| To compare the incidence of Emergence agitation assessed by using the WATCHA Scale |
At the end of surgery and anaesthesia |
| To compare the time for post operative discharge from Post Anaesthesia Care Unit (PACU) by Modified Aldrete Scoring |
At the end of PACU stay |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/11/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Preoperative anxiety can occur in as much as 80% of surgical patients.11 Two vulnerable groups of patients are females and children. While most female adults are usually concerned about the uncertainty of their future, their family, the success of the operation, and the safety of anaesthesia, the children, by contrast, will experience varying degrees of separation anxiety before an operation. Both psychological and pharmacological approaches are effective in decreasing preoperative anxiety. A child’s preoperative anxiety can pose a significant challenge for the anaesthetic team and can be distressing for parents. Evidence suggests that preoperative anxiety is associated with adverse outcomes, both clinical (increased requirements for analgesics and emergence delirium) and behavioural (sleep disturbances and enuresis)12 Various drugs have been used as premedication to allay anxiety and facilitate the smooth separation of the child from parents such as midazolam, ketamine, dexmedetomidine, clonidine, melatonin and sufentanil.1 The ideal premedicant should be readily acceptable and should have a rapid onset of action, reliable effect and faster recovery from the sedative effect of the drug. Since there is a discrepancy in the results of various studies on the superiority of the atomised form of one drug given intranasally over another and there is no study comparing the effectiveness of intranasal atomised ketodex versus midazolam for premedication in children aged 1 to 10 years of age. Therefore, we would like to compare the effectiveness of intranasal atomised ketodex using dexmedetomidine at a dose of 1 μg/kg and ketamine at a dose of 3 mg/kg with intranasal atomised midazolam 0.4 mg/kg in children aged 1 to 10 years for premedication undergoing spinal dysraphism surgery and we hypothesize that intranasal atomized ketodex will be non-inferior to intranasal midazolam as a premedicant for anxiolysis and sedation in children aged 1-10 years undergoing spinal dysraphism surgery. |