| CTRI Number |
CTRI/2021/11/038091 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of two different routes of administration of dexmedetomidine with oral ketamine to relieve anxiety before operation in young children |
|
Scientific Title of Study
|
Comparison of two different routes of administration of dexmedetomidine (intranasal and nebulised ) alongwith oral ketamine as a premedication in Children 1-5 years of age undergoing elective surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Rana |
| Designation |
Post graduate student in anaesthesiology and intensive care |
| Affiliation |
Adesh institute of Medical sciences & Research,Bathinda |
| Address |
Room no 310 c block girls hostel adesh university
Department of Anaesthesiology & Intensive care,Adesh institute of Medical sciences & Research,Bathinda
house no- 1932 sector 45 burail chandigarh
Bathinda
PUNJAB
151001
India |
| Phone |
7009703862 |
| Fax |
|
| Email |
priyankanesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upinder kaur |
| Designation |
Professor Department of Anaesthesiology and intensive care,Bathinda |
| Affiliation |
Adesh institute of Medical sciences & Research,Bathinda |
| Address |
Department of Anaesthesiology & Intensive care,Adesh institute of Medical sciences & Research,Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9815033776 |
| Fax |
|
| Email |
upindermander01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upinder kaur |
| Designation |
Professor Department of Anaesthesiology and intensive care,Bathinda |
| Affiliation |
Adesh institute of Medical sciences & Research,Bathinda |
| Address |
Department of Anaesthesiology & Intensive care,Adesh institute of Medical sciences & Research,Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9815033776 |
| Fax |
|
| Email |
upindermander01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh institute of medical sciences & medical research,Bathinda,punjab,151001 |
|
|
Primary Sponsor
|
| Name |
Adesh institute of Medical sciences ResearchBathinda |
| Address |
Adesh institute of Medical sciences & Research,Bathinda,Punjab,151001
|
| Type of Sponsor |
Private 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 Priyanka Rana |
Adesh institute of Medical sciences & Research,Bathinda |
Room no -310 c block girl hostel
Department of anesthesiology and intensive care,
Adesh institute of Medical sciences & Research(AIMSR)Bhucho khurd barnala road,Bathinda
151001
Bathinda
PUNJAB |
7009703862
priyankanesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EthicsCommittee Adesh University |
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 |
dexmedetomidine (intranasal and nebulised ) alongwith oral ketamine as a premedication |
Comparison of two different routes of administration of dexmedetomidine (intranasal-2ug/kg, and nebulised 3ug/kg ) alongwith oral ketamine in the dose of 3mg/kg as a premedication in Children 1-5 years of age undergoing elective surgery |
| Comparator Agent |
Dexmedetomidine(intranasal and nebulised) routes |
Comparison of two different routes of administration of dexmedetomidine (intranasal-2ug/kg, and nebulised 3ug/kg ) alongwith oral ketamine in the dose of 3mg/kg as a premedication in Children 1-5 years of age undergoing elective surgery |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 1-5 years
2. Both genders
3. ASA grade 1,2
4. Paediatric patient undergoing below umbilical surgery
5. Non-emergency surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Age >5 years
2. Non assenting parents for their child
3. Known sensitivity to ketamine or dexmedetomidine,
4. Paediatric patient of ASA Grade 3,4
5. Any known congenital heart diseases, raised intracranial pressure, raised intraocular pressure or mental retardation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Sedation score
2. Parental separation anxiety scale
3. Medication and mask acceptance scale
4. Recovery time
5. FLACC scale
6. Consolability scale
7. Emergence agitation scale
8. Wong baker scale
9. Modified aldrete score
|
Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min
T0- time just before giving premedication and noting down vital parameters
T1- time of giving premedication
T2- time after 10 minutes of premedication and assessing sedation scale
T3- time after 20 minutes of premedication
T4- time after 30 minutes of premedication and shifting the patient to OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sedation score
2. Parental separation anxiety scale
3. Medication and mask acceptance scale
4. Recovery time
5. FLACC scale
6. Consolability scale
7. Emergence agitation scale
8. Wong baker scale
9. Modified aldrete score
|
T5- time 4 hours after completion of surgery, see for any post operative pain and adverse event
T6- time 8 hours after completion of surgery, see for any post operative pain and adverse event
T7- time 12 hours after completion of surgery, see for any post operative pain and adverse event
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/11/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premedication for children is given to relieve preoperative stress and anxiety as seen in paediatric patients undergoing any surgery.along with fear of separation from parents , this anxiety is present along with adverse outcomes via elevation of stress markers,hemodynamic instability and impacting postoperative recovery and unstable vitals.So to allay this preoperative anxiety and achieve smoother induction of anaesthesia,a variety of pharmacological and non pharmacological methods have been proposed. various medications have been used through intravenous routes, but still not acceptable due to fear of needle, so dexmedetomidine which is an alpha 2 agonist, through two different routes( intranasal and nebulised) along with oral ketamine which is a non barbiturate cyclohexanone derivative produces sedation,analgesia,amnesia and anxiolysis without respiratory depression.so we are going to compare two routes of dexmedetomidine along with oral ketamine in this study as a premedication and assess various outcomes like sedation score, parental separation anxiety scale,medication and mask acceptance scale,recovery time,FLACCscale,consolabilty scale,emergence agitation scale,wong baker scale,modified adrete scale as various studies have been conducted using intranasal dexmedetomidine and nebulised dexmedetomidine alone as well as in combination with ketamine with good analgesic and antianxiety effect,also these procedures are standard and routine and so we will make sure the comfort and safety of patient is not compromised and no financial burden is put on the patient. |