| CTRI Number |
CTRI/2025/07/090838 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing Midazolam, Ketamine, and Dexmedetomidine as Sedation Options for Children Undergoing Radiology Scans |
|
Scientific Title of Study
|
Comparison of midazolam, ketamine and dexmedetomidine as premedications for radiological imaging in children under 10 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REXINA DARTHY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
A BLOCK
DEPARTMENT OF PAEDIATRCIS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE CHETTINAD ACADEMY AND RESEARCH EDUCATION Chennai TAMIL NADU 603103 India |
| Phone |
9043593599 |
| Fax |
|
| Email |
rexinadarthyjs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR JAISHREE |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
CHETTINA HOSPITAL AND RESEARCH INSTITUTE |
| Address |
A BLOCK
DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE CHETTINAD ACADEMY AND RESEARCH EDUCATION Chennai TAMIL NADU 603103 India |
| Phone |
9444362134 |
| Fax |
|
| Email |
vsdvnjshr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JAISHREE |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
CHETTINA HOSPITAL AND RESEARCH INSTITUTE |
| Address |
A BLOCK
DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE CHETTINAD ACADEMY AND RESEARCH EDUCATION Chennai TAMIL NADU 603103 India |
| Phone |
9444362134 |
| Fax |
|
| Email |
vsdvnjshr@gmail.com |
|
|
Source of Monetary or Material Support
|
| A BLOCK
DEPARTMENT OF PAEDIATRICS CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
TAMIL NADU - 603103
INIDA |
|
|
Primary Sponsor
|
| Name |
DR REXINA DARTHY |
| Address |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| 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 REXINA DARTHY |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
A BLOCK
DEPARTMENT OF PAEDIATRICS
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
CHETTINAD ACADEMY AND RESEARCH EDUCATION
TAMIL NADU - 603103 Chennai TAMIL NADU |
9043593599
rexinadarthyjs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHETTINAD ACADEMY OF RESEARCH AND EDUCATION INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
sedative drugs such as midazolam, ketamine, dexmedetomidine |
Children undergoing radiological investigations are given intravenous sedative agents to prevent anxiety during imaging |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children under 18 years of age requiring sedative agents for investigation purposes |
|
| ExclusionCriteria |
| Details |
Patients requiring mechanical ventilation and intravenous inotropic support and those with cyanotic CHD, second- and third-degree heart. Children with muscular dystrophies, multiple congenital anomalies, hepatic or renal dysfunction, and allergy to any of the used drugs were excluded. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children. |
To evaluate and compare the effect of sedation by dexmedetomidine, midazolam, ketamine in a group of children under 10 years of age , for a period of 24 hours post sedations |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION |
TO COMPARE THE EFFECTS OF KETAMINE, MIDAZOLAM, DEXMEDETOMIDINE ON THE DURATION OF SEDATION AND ADVERSE EVENTS THAT OCCUR WITHIN 24 HOURS AFTER SEDATION |
|
|
Target Sample Size
|
Total Sample Size="81" Sample Size from India="81"
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)
|
23/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 are a population with a high level of anxiety. The prevention of perioperative stress in a frightened child is important to render the child calm and cooperative for smoother induction. Intranasal premedication is easy and safe, and the drug is rapidly absorbed into the systemic circulation, ensuring early onset of sedation in children and good effectiveness. Pain, fear, anxiety, and anger are the main emotional components to be dealt by a pedodontist while treating a child. It is generally agreed that most fearful and uncooperative children should be managed with behavioral (nonpharmacologic) management procedures such as tell-show-do, positive reinforcement, controlled expectations, modeling, and suggestion.The primary aim of pharmacological sedation in paediatrics is to transform the patient’s behavior to a level that allows employing behavior management techniques. Intranasal administration of the drugs is well tolerated by children, effective and fast acting as this site is highly vascularized and very permeable for drug administration, ensuring rapid absorption into systemic circulation. This proposal may suggest that sedative agents such as midazolam, ketamine, dexmedetomidine evaluated in this study in a paediatric population can be used safely and effectively in uncooperative pediatric patients for producing conscious sedation. |