| CTRI Number |
CTRI/2022/03/041180 [Registered on: 17/03/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of three sedative agents; intranasal dexmedetomidine, intranasal midazolam and inhalation nitrous oxide for children undergoing dental treatment |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of intranasal atomised dexmedetomidine, atomised midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janiani Palak Ramesh |
| Designation |
Post Graduate |
| Affiliation |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital 162, Poonamalle High Road, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9820775554 |
| Fax |
|
| Email |
palakjaniani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Gurunathan |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals 162, Poonamalle High Road, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Gurunathan |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals 162, Poonamalle High Road, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, Chennai |
|
|
Primary Sponsor
|
| Name |
Janiani Palak Ramesh |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital, 162, Poonamalle, Chennai 600077 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Janiani Palak Ramesh |
Clinic Number 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College |
162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU |
9820775554
palakjaniani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Commitee Certificate (IHEC) |
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, Intranasal Midazolam |
Given using an intranasal atomization device at a dose of 1 µg/kg, given using intranasal atomization device at a dose of 0.3 mg/kg |
| Comparator Agent |
Nitrous oxide-Oxygen |
Inhalation nitrous-oxide oxygen is the gold standard. Maximum titration is 70% Oxygen and 30% Nitrous oxide |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I Category
2.Behavior category: Frankl Scale 2 negative
3.Requiring pulpectomy in at least three posterior teeth in the lower arch
4.No cognitive impairment |
|
| ExclusionCriteria |
| Details |
1.Patients who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam.
2.Children with any condition that predisposes them to airway obstruction or difficulties (eg adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp).
3.Frankl scale #1 (definitely negative)
4.Children with upper or lower respiratory tract infections
5. Children with special health care needs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of sedation and behaviour
Intra- and Post-op pain |
Assessment of sedation and behaviour
Intra- and Post-op pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physiologic signs (Blood pressure, SPO2, Pulse rate)
Recovery time
Side effects |
During administration of local anaesthesia, during insertion of mouth prop, during obturation
Post treatment |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental treatment has always been considered as an anxiety-provoking experience for many children. For these children, many different forms and different drugs have been used by operators for their sedation and dental treatment. These commonly include midazolam (i.v, oral or intranasally), dexmedetomidine or nitrous oxide-oxygen. Midazolam is considered as the “ potentially idel sedative agent†with a wide toxic/therapeutic ratio and safety margin. Dexmedetomidine is one of the safest drugs causing least respiratory depression. Nitrous oxide-oxygen is the “standard technique’†used in dental operatories for concious sedation. All 3 agents have their own advantages and comparing them will help us to conclude which is the most effective and safest for paediatric dental treatment. Moreover, intranasal route allows patient to maintain nil per oral and therefore chances of aspiration are very less.
Aim: To compare the efficacy of intranasal atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment
Objectives : To evaluate & compare: 1. the sedative efficacy of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment. 2. the effect on behaviour after the use of atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment. 3. the recovery time after administration of atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide- oxygen for concious sedation in pediatric dental treatment. 4. the intra- & post-op pain during treatment after administration of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.
|