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CTRI Number  CTRI/2023/12/060666 [Registered on: 22/12/2023] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Studying How children Feel and React When They are treated with Laughing Gas during dental procedure 
Scientific Title of Study   Physiological and psychological effectiveness of rapid and slow induction of nitrous oxide inhalation sedation in a pediatric patient undergoing dental procedure: A randomized clinical study 
Trial Acronym  NOIS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Sneha Dori 
Designation  Student 
Affiliation  K M Shah Dental College And Hospital 
Address  K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodiya Vadodara
Dentination dental clinic,SF13-14 Earth icon beside sardar estate bapunagar vadodara 390006
Vadodara
GUJARAT
391760
India 
Phone  7575049214  
Fax    
Email  snehadori16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anshula Deshpande  
Designation  Professor 
Affiliation  K M SHAH DENTAL COLLEGE AND HOSPITAL  
Address  K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodiya Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7600916400  
Fax    
Email  dranshula@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sneha Dori  
Designation  Student 
Affiliation  K M SHAH DENTAL COLLEGE AND HOSPITAL  
Address  K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodiya Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7575049214  
Fax    
Email  snehadori16@gmail.com  
 
Source of Monetary or Material Support  
K M Shah dental college and hospital Pipariya Waghodiya Vadodara 
 
Primary Sponsor  
Name  Dr Sneha Dori  
Address  K M Shah dental college and hospital Pipariya Waghodiya Vadodara  
Type of Sponsor  Research institution and hospital 
 
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 SNEHA DORI  K M Shah Dental College And Hospital  Sumandeep Vidyapeeth Pipariya Waghodiya Vadodara 391760
Vadodara
GUJARAT 		 7575049214

snehadori16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CHILDREN WITH UNCOOPERATIVE BEHAVIOUR 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  fast induction of nitrous oxide inhalation sedation  fast inhalation of gas to save time during treatment which is inhaled for 30-45 minutes in pediatric age group 
Comparator Agent  slow induction of nitrous oxide inhalation sedation for 30-45 minutes   nitrous oxide gas is used as pharmacological behavior management technique which is administered for 30-45 minutes  
 
Inclusion Criteria
Modification(s)  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) Physical Status I and II
Frankl behaviour rating scale of 3 and 4
Preoperative heart rate of 80 to 140 beats per minute and Respiratory rate of 24-30 beats per minute.
A maximum blood pressure reading of 140/100 mmHg.
Patients who require LA administration for dental procedures. 
 
ExclusionCriteria 
Details  Patient with any chronic systemic illness.
Parents who did not give consent
Children with active upper respiratory tract infections, obstructive mouth breathing
Predisposing factors causing airway obstruction such as adenoid hyperplasia, nasal septum problems, nasal polyps, and enlarged turbinates.
Patients having claustrophobia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
pain scale, sedation scale   24 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
psychomotor scale  24 hour 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2024 
Date of Study Completion (India) 25/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 in process 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Nitrous oxide–oxygen (N2O–O2) inhalation sedation has been recognized as a safe and effective technique to reduce anxiety, produce analgesia, and enhance effective communication between a patient and a health�’care provider. N2O is a nonirritating, colorless, inert gas with a faint sweet smell and odor. During rapid induction, pre adjusted concentrations of N2O with O2 is administered directly as a STAT dose in an uncooperative child till he/she gains his/her composure. After the child settles down, N2O concentrations are appropriately adjusted either upward or downward. very few studies have mentioned the efficacy of the rapid induction technique using preadjusted mix of 30% N2O + 70% O2 for sedation in children while comparing it with 50% N2O+ 50% O2 and monitoring the procedure for adverse effects such as hypoxia, nausea, and vomiting. according to null hypothesis There is no difference in changes in physiological and psychomotor effects on pediatric patients under different concentrations of N2O –O2 inhalation sedation.The current study aims to evaluate and compare the changes in physiological and psychomotor effects on pediatric patients under different concentrations of N2O –O2 inhalation sedation and to analyze the post-sedation effects of nitrous oxide sedation. 
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