| CTRI Number |
CTRI/2025/06/089705 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A comparison of three methods to help uncooperative children stay calm during dental treatment using nasal sedatives and laughing gas. |
|
Scientific Title of Study
|
Comparative evaluation of Sedation Protocols for procedural sedation in Paediatric
Dentistry: Dexmedetomidine(intranasal) plus Nitrous Oxide, Midazolam(intranasal) plus Nitrous Oxide and Nitrous Oxide Monotherapy for Uncooperative Patients- a crossover academic 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 |
Aswathi Venugopal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Room no.444, Dental Department ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
Room no.444, Dental Department ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9633933067 |
| Fax |
|
| Email |
m02jul024046@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Cheranjeevi Jayam |
| Designation |
Additional Professor |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
444, Dental OPD ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
444, Dental OPD ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8894337313 |
| Fax |
|
| Email |
drjayam.dental@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aswathi Venugopal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Room no.444, Dental Department ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
Room no.444, Dental Department ,4th floor, OPD Block, AIIMS Mangalagiri, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9633933067 |
| Fax |
|
| Email |
m02jul024046@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS MANGALAGIRI |
| Address |
AIIMS MANGALAGIRI,Mangalagiri, Andhra Pradesh 522503 |
| 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 |
| Dr Aswathi Venugopalan |
AIIMS MANGALAGIRI |
Room no: 444, Dental Department, 4th Floor, AIIMS Mangalagiri, Mangalagiri, Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH |
9633933067
m02jul024046@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences,Mangalagiri, Andhra Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine + Nitrous Oxide |
A combination of intranasal dexmedetomidine (1.0–3.0 mcg/kg) using a mucosal atomization device (MAD) followed by inhalation of nitrous oxide (up to 50%) for procedural sedation. This combination aims to provide sedation with minimal respiratory depression and improve cooperation in pediatric dental patients. |
| Intervention |
Dexmedetomidine (intranasal) + Nitrous oxide |
A combination of intranasal midazolam (0.1–0.2 mg/kg) administered using a mucosal atomization device (MAD) and inhaled nitrous oxide (up to 50%) delivered through a nasal mask. Premedication is intended to enhance mask acceptance and manage uncooperative behavior in pediatric dental patients. Sedation depth and behavioural response are evaluated using standard behavioural scales. |
| Comparator Agent |
Nitrous Oxide Monotherapy |
Nitrous oxide (10–50%) delivered via nasal mask for conscious sedation, with intranasal saline used for blinding. This arm serves as a control to compare the effectiveness of sedative combinations. The onset, behaviour, and physiological parameters are recorded and analyzed using standardized scales. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Behavioural category: Frankl Behaviour Rating Scale negative and definitely negative.
2.Patient’s whose approval has been granted by anaesthesiologist for the proposed procedure.
3. Patient classified as American Society of Anaesthesiologist (ASA) physical status
classification I and II.
4. Patients requiring a minimum of three dental procedures including deep restorations,
pulpectomy, pulpotomy or extractions during the study period |
|
| ExclusionCriteria |
| Details |
1. Patients with conditions that may cause severe airway obstruction (e.g., adenoid
hyperplasia, nasal septum issues, enlarged turbinates, nasal polyps) , with upper or lower
respiratory tract infections, mouth breather or with chronic pulmonary disease.
2. 3. 4. Patient with history of middle ear surgery, otitis media or infections.10
Individuals exhibiting severe cognitive deficits.
Patients who have recently used medications such as bleomycin sulfate 10,erythromycin or
anticonvulsants that may impact the pharmacokinetics of the drugs to be used.
5. Patient with any autoimmune disease or immunosuppressive therapy.10
6. Patient with methionine synthase deficiency, methylene tetrahydrofolate reductase
deficiency or vitamin B12 deficiency10
.
7. Surgery which involves anterior surface of maxilla ( e.g.: extraction of an impacted tooth,
8. removal of odontomes and cysts )
Any prior diagnosis of systemic diseases that may affect sedation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate sedation effectiveness using standard behavioral scales including Wood Mask Acceptance Scale, Frankl Behaviour Rating Scale, Houpt Behaviour Scale and AAPD Sedation Effectiveness Rank. |
Pre-sedation, during sedation, and immediate post-sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess physiological parameters (heart rate, blood pressure, oxygen saturation) and incidence of adverse effects (sneezing, vomiting, respiratory distress, etc.) across all three sedation protocol |
Baseline (pre-sedation)
During procedure
Recovery period (immediate post-procedure) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aspedod@gmail.com].
- For how long will this data be available start date provided 19-10-2026 and end date provided 19-10-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a prospective, randomized, crossover clinical trial conducted in a pediatric dental setting. The study aims to compare the effectiveness of three conscious sedation protocols in managing uncooperative pediatric dental patients: 1) intranasal dexmedetomidine with nitrous oxide, 2) intranasal midazolam with nitrous oxide, and 3) nitrous oxide monotherapy. Children aged 3 to 12 years, classified as negative or definitely negative according to the Frankl Behaviour Rating Scale, will be included. Each participant will receive all three interventions across separate visits in randomized order. Behavioural outcomes will be measured using Wood’s Mask Acceptance Scale, Frankl Scale, Houpt Behaviour Rating, and AAPD sedation effectiveness rank. Physiological parameters and adverse events will be monitored. The study will help identify the most effective and child-friendly sedation protocol for use in pediatric dental procedures. A total of 30 participants will be enrolled at a single centre in India. |