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CTRI Number  CTRI/2025/05/087509 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial. 
Scientific Title of Study   Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHWETA TYAGI 
Designation  Post Graduate 
Affiliation  SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL 
Address  Flat- 83, Ashirwad apartment
plot -11, sector- 12
New Delhi
DELHI
110078
India 
Phone  09654325788  
Fax    
Email  tshweta964@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SHWETA TYAGI 
Designation  Post Graduate 
Affiliation  SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL 
Address  Flat- 83, Ashirwad apartment
plot -11, sector- 12

DELHI
110078
India 
Phone  09654325788  
Fax    
Email  tshweta964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHWETA TYAGI 
Designation  Post Graduate 
Affiliation  SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL 
Address  Flat- 83, Ashirwad apartment
plot -11, sector- 12

DELHI
110078
India 
Phone  09654325788  
Fax    
Email  tshweta964@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  shweta tyagi 
Address  shree bankey bihari dental college  
Type of Sponsor  Other [] 
 
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 
SHWETA TYAGI  shree bankey bihari dental college   Flat- 83, Ashirwad apartment plot -11, sector- 12 Dwarka, New Delhi- 110078
South West
DELHI 
09654325788

tshweta964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical clearance certificate   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children with no systemic disease,No known allergies or contraindications to the sedative drugs planned for use.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1. INCLUSION CRITERIA: -
a) Children between 4 and 7 years old.
b) Need for local anesthesia for dental, minor surgical, or other procedures where the child might not cooperate without sedation.
c) Children with no systemic disease
d) No known allergies or contraindications to the sedative drugs planned for use.

 
 
ExclusionCriteria 
Details  2. EXCLUSION CRITERIA: -

a) Children below 4 and above 7 years old.
b) Children with severe systemic diseases.
c) Dental treatment not requiring injectable LA.
d) Subjects exhibiting positive behaviour.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.  In a randomized study, 60 children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3, received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute before the local anaesthetic administration (n=20), Group C- preadjusted mixture of nitrous oxide–oxygen sedation was administered in the concentration of 30–70% using Matrx Porter Digital Relative analgesia machine (n-20). 
 
Secondary Outcome  
Outcome  TimePoints 
comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.  1. To determine the efficacy of oral melatonin to intranasal midazolam
2. Efficacy of intranasal midazolam to nitrous oxide sedation
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/07/2025 
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="0"
Months="6"
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  

AIM- To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration.

Material & Methodology- In a randomized study, 60 children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3, received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute before the local anaesthetic administration (n=20), Group C- preadjusted mixture of nitrous oxide–oxygen sedation was administered in the concentration of 30–70% using Matrx Porter Digital Relative analgesia machine (n-20).

Subjective pain perception during injection was measured using Wong Baker Faces Pain Rating Scale and objective pain by sound, eye, body movement rating scale and Modified Dental Anxiety Scale score before and after local anaesthesia administration, patient satisfaction and comfort levels scores.

 
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