| CTRI Number |
CTRI/2024/04/065765 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on effect of nitrous oxide oxygen sedation techniques in children. |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of interrupted and continuous nitrous oxide oxygen sedation as administration technique in anxious children of 4 to 8 years of age- 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 |
Dr Avani Ramesh Doiphode |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Room No - 108, Department of Paediatric and Preventive Dentistry,
Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
9075725395 |
| Fax |
|
| Email |
avanidoiphode5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Room NO- 108, Department of Paediatric and Preventive Dentistry,
Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ritesh Kalaskar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
Room NO- 108, Department of Paediatric and Preventive Dentistry,
Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur.
Nagpur MAHARASHTRA 440003 India |
| Phone |
8550938585 |
| Fax |
|
| Email |
riteshpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, Nagpur, Maharashtra, India. 440003 |
|
|
Primary Sponsor
|
| Name |
Dr Avani Ramesh Doiphode |
| Address |
Swamiraj Niwas, At post-Varse, Tal-Roha, Dist-Raigad,
Maharashtra, India. 402109 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Avani Ramesh Doiphode |
Government Dental College and Hospital, Nagpur. |
Room No- 108,
Department of
Paediatric and
Preventive Dentistry. Nagpur MAHARASHTRA |
9075725395
avanidoiphode5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Nagpur- Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous Nitrous oxide oxygen (N2O-O2) sedation |
Continuous N2O-O2 sedation administration technique involves initial administration of oxygen(O2) for 3 minutes, followed by administration of 50%-50% of O2 and nitrous oxide(N2O). The 50%-50% of N2O and O2 will be administered continuously till the end of complete planned treatment of pulpectomy which may approximately take around 45-50 minutes and at the end of treatment again administration of O2 for 5 minutes. |
| Intervention |
Interrupted Nitrous oxide oxygen (N2O-O2) sedation |
In the case of mildly to moderately anxious children, interrupted N2O-O2 sedation administration technique involves initial administration of oxygen(O2) for 3 minutes, followed by administration of 50%-50% of O2 and nitrous oxide(N2O) for 5 minutes. Once profound local anesthesia has been established, it becomes possible to interrupt the continuous administration of N2O-O2 sedation while still effectively managing anxiety and maintaining desired behaviour. We assume that if behaviour issues related to local anesthetic administration alone have been successfully addressed, 100% oxygen may be administered and nitrous oxide will be stopped, offering a potential means of reducing chronic exposure of the dental team to potentially hazardous levels of ambient nitrous oxide and to reduce the chance of over sedation to patient. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children with ASA physical status classification I.
Patient with unilateral or bilateral carious first or second deciduous molar in need of treatment.
Children with anxiety score 3 or 4 on the Venhams anxiety scale.
Children with frankl behaviour rating of 3 or 4.
|
|
| ExclusionCriteria |
| Details |
Children below age of 4 years of age and above 9 years of age
Children with ASA physical status classification II, III, IV.
Children with modified frankl’s behaviour rating scale 1 and 2.
Highly uncooperative children
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sedation level
|
Baseline, during the treatment and post-treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Psychomotor analysis
2. Behaviour of the patient |
Baseline, during treatment & post-treatment |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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
|
Nitrous oxide -oxygen
conscious sedation (N2O- O2 sedation) is a commonly used technique in
paediatric dentistry to manage anxiety and discomfort in patients undergoing
dental procedures.This technique helps to reduce the physiological
and psychological stress in anxious paediatric patients. Various benefits of using
N2O- O2 sedation technique are its properties such as anxiolysis, mild analgesia, and amnesia.
Nevertheless, nitrous oxide poses a potential risk to clinical staff
regularly administering inhalational sedation. There is substantiated evidence
that prolonged exposure to nitrous oxide gas may result in hematological,
reproductive, and neurological issues. Although the use of scavenging equipment, proper techniques, and well-ventilated surgical
environments has notably reduced staff exposure levels, there remains some
residual pollution within the surgical setting.
The traditional approach to N2O-O2 sedation
involves the continuous administration of N2O- O2 throughout a dental procedure to ensure the ongoing cooperation of the
patient. In the case of mildly to moderately anxious children,
once profound local anesthesia has been established, it becomes possible to
interrupt the continuous administration of N2O-O2 sedation while still
effectively managing anxiety and maintaining desired behaviour. We assume that
if behaviour issues related to local anesthetic administration alone have been
successfully addressed, 100% oxygen may be administered, offering a potential
means of reducing chronic exposure of the dental team to potentially hazardous
levels of ambient nitrous oxide and to reduce the chance of over sedation to
patient.
Hence, this study is planned to investigate
the impact and sedation level achieved by interrupted N2O-O2 sedation
administration, following the achievement of profound local anesthesia, on the physical, physiological, psychological
parameters and behaviour of paediatric
dental patients with mild to moderate anxiety during the rehabilitation of
molars. |