| CTRI Number |
CTRI/2025/09/094000 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of different concentrations of nitrous oxide gas in reducing pain during dental injections in children |
|
Scientific Title of Study
|
Evaluation of pain perceived during local anesthesia administration with different concentrations of nitrous oxide sedation in preadolescent children: A randomized crossover 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 |
Charanya S |
| Designation |
Post graduate |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Paediatric and Preventive Dentistry, Dental block, room no. 8, SRM Dental College, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India
Chennai
TAMIL NADU
600089
India |
| Phone |
9655590226 |
| Fax |
|
| Email |
cs3956@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar P |
| Designation |
Reader |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Paediatric and Preventive Dentistry, Dental block, room no. 8, SRM Dental College, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
shankarp1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar P |
| Designation |
Reader |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Paediatric and Preventive Dentistry, Dental block, room no. 8, SRM Dental College, Bharathi Salai, Ramapuram, Chennai 600089, Tamil Nadu, India
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
shankarp1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Dental College, Bharathi Salai, Ramapuram, Chennai-600089 |
|
|
Primary Sponsor
|
| Name |
Charanya S |
| Address |
Department of Paediatric and Preventive Dentistry, dental block, room no. 8, SRM Dental College, Bharathi Salai, Ramapuram Chennai 600089 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Charanya S |
SRM Dental College, Ramapuram |
Department of Paediatric and Preventive Dentistry, dental block, room no. 8, SRM Dental College, Bharathi Salai, Ramapuram, Chennai- 600089
Chennai
TAMIL NADU |
9655590226
cs3956@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged 7–12 years requiring treatment under local anaesthesia through inferior alveolar nerve block (IANB) in each visit for 3 visits |
| Patients |
(1) ICD-10 Condition: Z012||Encounter for dental examination and cleaning, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A: 30% Nitrous oxide |
Dose/Concentration: 30% Nitrous oxide with 70% Oxygen
Route of Administration: Inhalation via nasal hood
Frequency: Single administration per dental visit
Total Duration: Administered continuously during the procedure (average 20–30 minutes, until completion of inferior alveolar nerve block - local anaesthesia )
Total appointments : 3 visits (crossover design with 1-week washout between each)
|
| Intervention |
Arm B: 40% nitrous oxide |
Dose/Concentration: 40% Nitrous oxide with 60% Oxygen
Route of Administration: Inhalation via nasal hood
Frequency: Single administration per dental visit
Total Duration: Administered continuously during the procedure (average 20–30 minutes, until completion of inferior alveolar nerve block local anaesthesia )
Total appointments: 3 visits (crossover design with 1-week washout between each)
|
| Comparator Agent |
Arm C: 100% oxygen |
Dose/Concentration: 100% Oxygen
Route of Administration: Inhalation via nasal hood
Frequency: Single administration per dental visit
Total Duration: Administered continuously during the procedure (average 20–30 minutes, until completion of inferior alveolar nerve block local anaesthesia )
Total appointments: 3 visits (crossover design with 1-week washout between each) |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged seven to twelve years requiring treatment under local anaesthesia through inferior alveolar nerve block in each visit for three visits.
Children with Frankel behaviour rating two.
Medically healthy children classified as American Society of Anesthesiologists physical status class one.
Children who can understand and follow instructions during the procedure.
Children whose parent or guardian have given consent and child assent for participation in the study. |
|
| ExclusionCriteria |
| Details |
Children with severe anxiety or uncooperative behavior that may require deeper sedation or general anesthesia.
History of respiratory conditions such as asthma, upper airway obstruction, or sleep apnea.
Neurological or developmental disorders that could affect sedation response such as epilepsy, autism spectrum disorder, or attention deficit hyperactivity disorder.
Allergy or hypersensitivity to nitrous oxide or local anesthetic agents.
Children with significant nasal congestion or conditions affecting nasal breathing.
Recent history of sedative or anxiolytic medication use within the past twenty four hours.
Severe gag reflex or conditions making nitrous oxide administration difficult.
Children who have undergone recent dental procedures with sedation within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pain perceived at different concentrations of nitrous oxide sedation (30% and 40%) and control (no sedation) during local anesthesia administration |
Subjective pain scale scored during administration of local anesthesia injection using Face, Legs, Activity, Cry, Consolability scale.
Objective pain scale scored Immediately after completion of local anesthesia injection using Wong Baker faces pain rating scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare anxiety levels before & after local anesthesia administration under thirty percent & forty percent nitrous oxide sedation.
To determine the depth of sedation achieved with thirty percent & forty percent nitrous oxide.
To compare recovery time following dental procedures under different sedation concentrations. |
Anxiety level by Visual Analogue Scale for Anxiety at baseline before local anesthesia & immediately after injection. Sedation depth by Wisconsin Sedation Scale at five minutes after induction of nitrous oxide oxygen inhalation before local anesthesia. Heart rate & oxygen saturation at baseline, during injection, immediately after, & during recovery every five minutes until complete recovery. Recovery status by Modified Aldrete Score during recovery every five minutes until complete recovery.
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
22/09/2025 |
| 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="1"
Months="0"
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
|
This randomized crossover clinical trial will evaluate the effect of different concentrations of nitrous oxide sedation (30% and 40%) on pain perception during local anesthesia administration in children aged 7–12 years. The study will include children who already require dental treatment under local anesthesia through an inferior alveolar nerve block (IANB) in three separate appointments. At each appointment, participants will receive one of three conditions: 30% nitrous oxide with oxygen, 40% nitrous oxide with oxygen, or 100% oxygen (control), in a randomized manner, with a one-week washout period between appointments. The primary outcomes are the pain perception during injection, assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and the subjective pain immediately after injection, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include anxiety levels using the Visual Analogue Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory for Children (STAI-CH), sedation depth using the Wisconsin Sedation Scale, physiological parameters (heart rate, blood pressure, and oxygen saturation), and recovery time using the Modified Aldrete Score. The study aims to investigate whether these lower concentrations can provide sufficient analgesia and reduce pain perception, potentially offering a safer alternative while maintaining clinical effectiveness |