| CTRI Number |
CTRI/2024/07/070023 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Laughing gas for child behavior management in dental clinic |
|
Scientific Title of Study
|
30 % Nitrous oxide - Oxygen (N2O/O2) Inhalation sedation -standard titration vs rapid titration - a randomized clinical 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 |
Mahima Shokhanda |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University |
| Address |
Room no -202, Department of Pediatric and Preventive Dentistry, Faculty of dental sciences, SGT University, Chandu Budhera Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9212519900 |
| Fax |
|
| Email |
mahimashokhanda2698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalu Verma |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no -202, Department of Pediatric and Preventive Dentistry, Faculty of dental sciences, SGT University, Chandu Budhera Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9871720820 |
| Fax |
|
| Email |
shalu.verma@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalu Verma |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no -202, Department of Pediatric and Preventive Dentistry, Faculty of dental sciences, SGT University, Chandu Budhera Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9871720820 |
| Fax |
|
| Email |
shalu.verma@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University ,Gurugram, Haryana- 122505, India |
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry Faculty of dental sciences SGT University |
| Address |
Room no -202, Department of Pediatric and Preventive Dentistry, Faculty of dental sciences, SGT University, Chandu Budhera Gurugram, Haryana-122505, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mahima Shokhanda |
SGT Dental Hospital |
Room no -202, Department of Pediatric and Preventive Dentistry, Faculty of dental sciences, SGT University, Chandu Budhera Gurugram
Gurgaon
HARYANA |
9212519900
mahimashokhanda2698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -SGT Dental College, Hospital and Research Institute (IEC-SGTDHCRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3-5 L/min 30% N202-O2 by standard titration technique for 30 minutes or less per procedure |
comparison of same concentration of nitrous oxide oxygen by different titration techniques that is in intervention nitrous oxide oxygen is given by rapid titration method while in comparator as comparator agent same concentration and percentage by conventional method that is step by step increase to 30 % waiting 10 minutes in between increase by 10% with maximum duration of 30 minutes |
| Intervention |
3-5 L/min 30% nitrous oxide oxygen(N2O2-O2) by rapid titration technique |
comparison of same concentration of nitrous oxide oxygen by different titration techniques that is in intervention nitrous oxide oxygen is given by rapid titration method while in comparator as comparator agent same concentration and percentage by conventional method that is step by step increase to 30 % waiting 10 minutes in between increase by 10% with maximum duration of 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
-Children indicated for procedure requiring administration of local anesthesia.
-Children falling under the ASA group I & II |
|
| ExclusionCriteria |
| Details |
- Children falling under the ASA group III & IV and V
- Chronic obstructive pulmonary diseases.
- Current upper respiratory tract infections (e.g., cold, cough, tonsillitis), sinusitis, or other conditions
(e.g., seasonal allergies) that inhibit nasal breathing.
- Recent middle ear disturbance or infection (e.g., acute otitis media).
- Recent (within 14 days) ear, nose, and/or throat operations.
- Raised intraocular pressure (e.g., glaucoma), up to three months post retinal surgery.
- Severe emotional disturbances or drug-related dependencies.
- Treatment with bleomycin sulfate.
- History of cobalamin (vitamin B12) deficiency. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of 30% nitrous oxide -oxygen (N2O / O2) inhalational sedation: standard
vs rapid titration on physiologic and analgesic parameters in pediatric patient while giving local anesthesia |
assessment of measuring scales before and after 10 minutes of giving local anesthesia for dental treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the patient & parent acceptance between two titration techniques |
assessment of measuring scales before & after 10 minutes of giving local anesthesia for dental treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
q Nitrous oxide/oxygen inhalation, also referred to as N2O/O2 analgesia/anxiolysis, is a safe and effective technique used to manage dental pain and anxiety.
q It may prove as invaluable pharmacological behavior management technique during challenging procedures like local anesthesia in pediatric patients.
q Technique of nitrous oxide administration can be divided into two types :1. slow titration or the standard titration 2. Rapid titration
q As there are not many studies reported regarding the rapid titration method the present study is planned to compare the effectiveness of two types of titration techniques.
|