CTRI Number |
CTRI/2018/04/013050 [Registered on: 04/04/2018] Trial Registered Retrospectively |
Last Modified On: |
23/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of nasal administration of two sedative drugs dexmedetomidine and fentanyl for sedation before surgery in children |
Scientific Title of Study
|
Comparison of intranasal dexmedetomidine versus intranasal fentanyl premedication in pediatric patients posted for elective surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mohit Parihar |
Designation |
Primary DNB Anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Operation Theatre Complex
Department of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Junior Resident Male Hostel
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Sonipat HARYANA 131305 India |
Phone |
9887363806 |
Fax |
|
Email |
drmohitparihar09@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Pranav bansal |
Designation |
Proffessor and head of department of anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Operation Theatre Complex
Department of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana B 4
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Sonipat HARYANA 131305 India |
Phone |
8222007555 |
Fax |
|
Email |
pranavbansal1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mohit Parihar |
Designation |
Primary DNB Anaesthesiology |
Affiliation |
Bhagat Phool Singh Government Medical College For Women |
Address |
Operation Theatre Complex
Department of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana Male Junior Resident Hostel
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana Sonipat HARYANA 131305 India |
Phone |
9887363806 |
Fax |
|
Email |
drmohitparihar09@gmail.com |
|
Source of Monetary or Material Support
|
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana |
|
Primary Sponsor
|
Name |
Bhagat Phool Singh Government Medical College For Women |
Address |
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonepat Haryana 131305 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Not applicable |
Not applicable |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Mohit Parihar |
Bhagat Phool Singh Government Medical College For Women |
Operation Theatre Complex
Department of Anaesthesiology
Sonipat HARYANA |
9887363806
drmohitparihar09@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA I/II Patients posted For Elective Surgery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Comparison between intranasal dexmedetomidine and intranasal fentanyl as premedication in children |
In the pre-operative room, 45 minutes before induction, group D will receive intranasal dexmedetomidine (1µg/kg) and group F will receive intranasal fentanyl (1.5µg/kg). |
Intervention |
Comparison of Intranasal premedication -dexmeditomidine or fentanyl in children |
Premedication is given 45 minutes prior to surgery |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
1. Children of American society of Anesthesiologists (ASA) grade I/II/ patients
2. Age group:- 2 to 10 yrs of age of all genders.
3. Weight ≤ 25kg.
4. Elective surgical procedures under General Anesthesia.
5. Parents and guardian willing to provide their voluntary written informed consent form for participation in the study.
|
|
ExclusionCriteria |
Details |
1. Parents and guardian not willing to participate in the present study.
2. History of allergy and hypersensitivity to dexmedetomidine / fentanyl.
3. Presence of upper respiratory tract infection and nasal pathology.
4. Patients having delayed milestones and who are mentally challenged.
5. Patients with any cardiac/respiratory disease.
6. Surgery lasting for more than 90 minutes will be excluded.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.To determine the time of onset and duration of sedation.
2.To determine the level of anxiety by child parent separation score.
3.To determine post-operative sedation and behavior score
|
1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery
2.Anxiety by child parent separation score at end of 45 minutes of premedication
3.Post-operative behaviour score at end of surgery
4.post-operative sedation score at the end of surgery and till 3 hours after surgery
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To determine hemodynamic parameter like heart rate, blood pressure, mean arterial pressure, SpO2 in each group.
2.To determine the side effect in each group if any.
|
In 45 minutes before surgery and intraoperative of maximum 90 minutes |
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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)
|
04/02/2018 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Children
are more anxious and fearful due to their limited cognitive capabilities, lack
of understanding of health care system and lack of self-control. Premedication
help to alleviate the stress and fear of treatment as well as to ease
child-parent separation and promote smooth induction of anesthesia. The
intramuscular, intravenous, subcutaneous and intraosseous routes provide
optimal drug delivery, but they are painful and children dislike the needle
prick. Multiple agents have been used to treat pre-operative anxiety and stress.
New drugs such as the α2 agonists have been introduce as an alternative for
premedication in pediatric patients. In our study we aim to compare the effect
of intranasal dexmedetomidine and intranasal fentanyl in pediatric patients
posted for elective surgery. A total of 88 patients will be randomly allocated
into 2 groups with 44 patients in each group. Group D will receive intranasal
dexmedetomidine 1µgm/kg and group F will receive intranasal fentanyl 1.5
µgm/kg, 45 minutes prior to induction of anesthesia. Patients will be monitored
pre-operatively for vitals parameters including heart rate, blood pressure,
oxygen saturation and sedation and child parent separation score.
Intra-operatively vitals and post-operatively behavior and sedation score will
also be monitored. Possible side- effects of these agents will be monitored and
managed. Thereafter, comparison will be made among the two groups based on the
data collected. The different variables and occurrence of side effects, if any,
would also be noted and compared amongst all groups.
|