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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  
Status 
Not Applicable 
 
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.

 

 

 

 

 
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