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CTRI Number  CTRI/2018/03/012807 [Registered on: 23/03/2018] Trial Registered Retrospectively
Last Modified On: 31/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Dexmedetomidine and Midazolam as Intanasal Premedication in Children 
Scientific Title of Study   A Comparative Study of Intranasal Dexmedetomidine and Intranasal Midazolam as Premedication in Children Undergoing Short Surgical Procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Fernandez 
Designation  Post Graduate Resident 
Affiliation  Department of Anaesthesiology 
Address  Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India 
Phone  08025631714  
Fax    
Email  rahul.rainmaker@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moses Charles DSouza 
Designation  Professor 
Affiliation  Department of Anaesthesiology and Critical Care 
Address  Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India 
Phone  08025631714  
Fax    
Email  drmosescharlesdsouza@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Moses Charles DSouza 
Designation  Professor 
Affiliation  Department of Anaesthesiology and Critical Care 
Address  Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
St. Johns Medical College Hospital, Sarjapur Road, Bangalore.
Bangalore
KARNATAKA
560034
India 
Phone  08025631714  
Fax    
Email  drmosescharlesdsouza@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Principle Investigator 
Address  St. Johns Medical College Hospital, Sarjapur Road, Bangalore. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Fernandez  St. Johns Medical College Hospital  Pediatric Surgery Operating Theater Complex
Bangalore
KARNATAKA 
08025631714

rahul.rainmaker@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
Modification(s)  
Health Type  Condition 
Patients  Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia
American Society of Anaestheiologists (ASA) Physical Status I & II grade of patients.
 
 
ExclusionCriteria 
Details  Parent refusal
Known allergy to the drugs under study.
Cardiac dysrhythmias and/or congenital heart disease
Psychotropic medication use
Mental retardation
Nasal disorders interfering with administration of medication as recurrent nasal bleeding or nasal masses.
Children who spat or refused intranasal administration of medication.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S).
Parental Separation Anxiety scale (PSAS).
Mask Acceptance Score(MAS). 
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes.
Parental Separation Anxiety scale (PSAS). 30 minutes.
Mask Acceptance Score(MAS). 30 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation  pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2016 
Date of Study Completion (India) 01/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Global Journal for Research Analysis. Volume-7, Issue-12, December-2018. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

SUMMARY

This study was conducted in the department of anesthesiology and critical care at the pediatric surgery operating theatre complex, St. John’s Medical College Hospital, Bangalore.

            In this study, 104 ASA grade I and II children between 2-10 years, who were scheduled for elective surgical procedures were observed. The patients that received intranasal Dexmedatomidine (1µg/kg) were allotted to group D and the patients that received intranasal Midazolam (0.2mg/kg) were put under group M.

            30 minutes after premedication with the intranasal drug, the Parental Separation Anxiety Score was assessed on a 4 point scale and sedation of the child was assessed using a 6 point Modified Observer’s Assessment of Alertness/Sedation Scale. Prior to anesthesia induction the Mask Acceptance Score was assessed using a 5 point scale.

            There was a marked variation between the two groups with regards to the parental separation. There was a statistically significant data which concluded the children premedicated with intranasal Dexmedetomidine separated much more easily than those premedicated with intranasal Midazolam.

            The Modified Observer’s Assessment of Alertness/Sedation scores showed a significantly better score in the Dexmedetomidine group compared to Midazolam, indicating a better degree of sedation among those premedicated with Dexmedetomidine.

            There was a statistically significant difference with respect to mask acceptance before induction of anesthesia. The patients premedicated with intranasal Dexmedetomidine had better mask acceptance compared to those premedicated with intranasal Midazolam.

            The demographic data recorded found no difference in the age or gender between the two groups.

            After premedication the children were monitored for 30 minutes at every 10 minute interval, prior to induction of anesthesia. Vital signs (heart rate, BP, respiratory rate and oxygen saturation) were recorded. After administering intranasal premedication it was found the there was a fall in heart rate, without significant fall in blood pressure in the patients who were administered Dexmedetomidine. There was no change in the respiratory rate or oxygen saturation.

            Intra-operatively, the vitals were monitored every 5 minute interval for 30 minutes and thereafter every 10 minutes till the end of the procedure. The intra-operative period showed no significant variation in the vital parameters between the two groups.

            Post operatively the children were monitored for 24 hours after the procedure. The vitals were stable and there were no adverse reactions in any of the children.

Therefore, based on these results it can be concluded that intranasal Dexmedetomidine (1 µg/kg) is more efficacious than intranasal Midazolam (0.2 mg/kg) for premedicating children undergoing short elective surgical procedures.

 

 
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