| CTRI Number |
CTRI/2026/03/105252 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Understanding of the effect of midazolam with nitrous oxide-oxygen compared to dexmedetomidine with nitrous oxide-oxygen in pediatric dentistry-a clinical trial |
|
Scientific Title of Study
|
comparative evaluation of the efficacy of midazolam - nitrous oxide/oxygen and dexmedetomidine - nitrous oxide/oxygen in pediatric dental procedures: a prospective single-blinded cross over study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
pooja nellore |
| Designation |
postgraduate |
| Affiliation |
mcods mangalore |
| Address |
manipal college of Dental Sciences,light house hill road,hampankatta Mangalore,karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6304717894 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
pooja nellore |
| Designation |
postgraduate |
| Affiliation |
mcods mangalore |
| Address |
manipal college of Dental Sciences,light house hill road,hampankatta Mangalore,karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6304717894 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
pooja nellore |
| Designation |
postgraduate |
| Affiliation |
mcods mangalore |
| Address |
manipal college of Dental Sciences,light house hill road,hampankatta Mangalore,karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6304717894 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pooja nellore |
| Address |
kasturba medical college, lighthouse hill road , hampankatta, mangalore, karnataka 575001. |
| Type of Sponsor |
Other [post graduate at a dental college] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
KMC lighthouse hill road, mangalore, hampankatta, 575001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Nellore |
Manipal College of Dental Sciences Mangalore |
VR9V+VPM, Kasturba Medical College, Light House Hill Road, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA |
09581224480
poojanellore94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
diseases of pulp and periapical tissues based on frankl behaviour rating |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparative evaluation of midazolam |
Behaviour, sedative effect, hemodynamic variables at a dose of .5 mg/ml |
| Comparator Agent |
Intranasal dexmedetomidine |
behaviour sedative effect at a dose of 2.0mcg/ml |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
ASA category 1
childs weight within normal range
frankl positive or negative behaviour children with atleast 2 carious lesions |
|
| ExclusionCriteria |
| Details |
children with identifiable risk factors for airway obstruction,
such as enlarged tonsils, or adenoids, nasal polyps, septal deviation and a Mallampati score of 3 or 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| houpt scale, ramsay sedation scale, aldrete score, frankls behaviour rating scale, hemodynamic parameters |
hemodynamic parameters at baseline and every 15 minutes until the procedure ends |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the amnestic effect between oral midazolam with nitrous oxide- oxygen & intranasal dexmedetomidine with nitrous oxide- oxygen using the amnesia test |
At baseline & 15 minutes after administration of the drug |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 2 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
to evaluate the effectiveness of oral midazolam with nitrous oxide - oxygen on sedation and behaviour of children using the houpt scale on administration. to observe the hemodynamic parameters in children after administration of oral midazolam with nitrous oxide oxygen to evaluate the effectiveness of intranasal dexmedetomidine with nitrous oxide oxygen on sedation and behaviour of children using the houpt scale on administration to observe the hemodynamic parameters in children after administration with intranasal dexmedetomidine with nitrous oxide - oxygen. |