| CTRI Number |
CTRI/2025/03/081696 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Dexmedetomidine and Dexmedetomidine-Ketamine combination efficacy as intranasal premedication in paediatric infraumbilical surgeries |
|
Scientific Title of Study
|
Comparison between effectiveness of Dexmedetomidine and Dexmedetomidine-ketamine combination as an intranasal premedication in paediatric infraumbilical surgeries |
| 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 Fehima Haris |
| Designation |
Junior resident |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9539833177 |
| Fax |
|
| Email |
fehimaharis04282@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna K |
| Designation |
Professor |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mumthas M S |
| Designation |
Assistant professor |
| Affiliation |
Government medical college Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college Kozhikode
Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9446467821 |
| Fax |
|
| Email |
msmumthas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Kozhikode
Kerala
India
Pin: 673008 |
|
|
Primary Sponsor
|
| Name |
Dr Fehima Haris |
| Address |
Junior resident
Government medical college Kozhikode
Kerala |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Fehima Haris |
Government medical college Kozhikode |
Operation theater
Department of paediatric surgery
Kozhikode
KERALA |
9539833177
fehimaharis04282@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government medical college Kozhikode |
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 |
| Comparator Agent |
Intranasal dexmedetomidine-ketamine combination |
Effectiveness of intranasal premedication with dexmedetomidine-ketamine combination is compared with intranasal dexmedetomidine alone in paediatric infraumbilical surgeries |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients of age 1-6 years of either sex undergoing elective infraumbilical surgeries of ASA physical status I or II |
|
| ExclusionCriteria |
| Details |
Known allergy to study drugs
Cardiac arrhythmia or congenital heart disease
Raised intracranial tension
Children with mental retardation
Intranasal mass or nasal bleeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of intranasal dexmedetomidine versus intranasal dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries |
Mask acceptance score will be assessed at the time of induction that is 30 minutes after giving premedication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess level of sedation using Ramsay sedation score
To determine Child-parent separation score |
Sedation assessed 15 & 30 minutes after premedication
Child- parent separation score assessed at the time of parental separation or 30 minutes after premedication |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/04/2025 |
| 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="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
|
This is a comparative observation study comparing effectiveness of intranasal dexmedetomidine 3mcg/kg with intranasal dexmedetomidine(2mcg/kg)-ketamine(2mg/kg) combination as a premedication in paediatric infraumbilical surgeries . While there has been much research on the individual effectiveness of dexmedetomidine and ketamine as paediatric premedication, there has been limited evidence on their combined efficacy . Our primary objective is to compare effectiveness of intranasal dexmedetomidine versus dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries. |