| CTRI Number |
CTRI/2025/06/088426 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
checking whether a drug called midazolam or the use of entertaining audio video would effectively reduce the childs stress before and after undergoing treatment in full anesthesia |
|
Scientific Title of Study
|
Comparison of Midazolam Premedication , Audiovisual Distraction and combination in Reducing Pre- and Post-Operative Anxiety in Children Aged 3–6 Years Undergoing Full Mouth Dental Rehabilitation Under General Anesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Suresh |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884927585 |
| Fax |
|
| Email |
ashishamudha011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
|
|
|
Primary Sponsor
|
| Name |
Ashish Suresh |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
|
| 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 Ashish Suresh |
Saveetha Dental College and Hospitals |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental college, No 162, poonamalle high road, velappanchavadi, Chennai 600077, Tamil Nadu, India
Thiruvallur
TAMIL NADU |
9884927585
ashishamudha011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) Registered under Government of India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Audio video distraction |
Animated videos of the childs favourite show to distract the child |
| Intervention |
Midazolam Premedication |
0.5mg per Kg in oral route, 30 minutes before the procedure |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children who are between 2 to 6 years old
2.Healthy children (ASA II)
3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention
4.No history of adverse reaction to anesthetic drugs or other medication
5.Children with no Physical or Cognitive disablities
6.Patient reporting to the dental operatory for the first time to minimize behavioural bias
7.Children requiring pulp therapy procedures |
|
| ExclusionCriteria |
| Details |
1.Allergy to lidocaine anesthetic drugs or midazolam
2.Local anesthetic or other drug administered within the week before the session in which they participated
3.Highly symptomatic teeth
4.Localised Lesion at the site of injection
5.Children with prior dental experience
6.Patients with developmental or linguistic disorders who cannot communicate properly
7.Children with medications which affect behaviour
8.Medically and systematically compromised patients
9.Patients with cognitive impairments or special needs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| stress levels measured using pulse rate, blood pressure and FLACC scores |
Baseline and immediately post full mouth rehabilitation under general anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/06/2025 |
| 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="0"
Months="1"
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
|
This randomized controlled trial aims to evaluate and compare the effectiveness of oral midazolam premedication and audiovisual distraction (AVD) in reducing anxiety levels in children aged 2 to 6 years undergoing full mouth dental rehabilitation under general anesthesia. Children will be randomly assigned to two groups: one receiving oral midazolam premedication and the other receiving audiovisual distraction using animated videos before induction of anesthesia. Anxiety levels will be assessed preoperatively and postoperatively using validated behavioral and physiological measures. The study seeks to determine the more effective method for managing perioperative anxiety in pediatric dental patients to enhance overall patient experience and outcomes. |