| CTRI Number |
CTRI/2025/05/087509 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: A Randomized Controlled Trial. |
|
Scientific Title of Study
|
Comparison of Efficacy in Sedation of Oral Melatonin, Intranasal Midazolam, and Inhaled Nitrous Oxide in Children Aged 4 to 7 Years: 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 |
SHWETA TYAGI |
| Designation |
Post Graduate |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Flat- 83, Ashirwad apartment plot -11, sector- 12 New Delhi DELHI 110078 India |
| Phone |
09654325788 |
| Fax |
|
| Email |
tshweta964@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SHWETA TYAGI |
| Designation |
Post Graduate |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Flat- 83, Ashirwad apartment plot -11, sector- 12
DELHI 110078 India |
| Phone |
09654325788 |
| Fax |
|
| Email |
tshweta964@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SHWETA TYAGI |
| Designation |
Post Graduate |
| Affiliation |
SHREE BANKEY BIHARI DENTAL COLLEGE AND HOSPITAL |
| Address |
Flat- 83, Ashirwad apartment plot -11, sector- 12
DELHI 110078 India |
| Phone |
09654325788 |
| Fax |
|
| Email |
tshweta964@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
shweta tyagi |
| Address |
shree bankey bihari dental college |
| Type of Sponsor |
Other [] |
|
|
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 |
| SHWETA TYAGI |
shree bankey bihari dental college |
Flat- 83, Ashirwad apartment
plot -11, sector- 12
Dwarka, New Delhi- 110078 South West DELHI |
09654325788
tshweta964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical clearance certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with no systemic disease,No known allergies or contraindications to the sedative drugs planned for use.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. INCLUSION CRITERIA: -
a) Children between 4 and 7 years old.
b) Need for local anesthesia for dental, minor surgical, or other procedures where the child might not cooperate without sedation.
c) Children with no systemic disease
d) No known allergies or contraindications to the sedative drugs planned for use.
|
|
| ExclusionCriteria |
| Details |
2. EXCLUSION CRITERIA: -
a) Children below 4 and above 7 years old.
b) Children with severe systemic diseases.
c) Dental treatment not requiring injectable LA.
d) Subjects exhibiting positive behaviour.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration. |
In a randomized study, 60 children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3, received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute before the local anaesthetic administration (n=20), Group C- preadjusted mixture of nitrous oxide–oxygen sedation was administered in the concentration of 30–70% using Matrx Porter Digital Relative analgesia machine (n-20). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparatively evaluate the efficacy of different premedication agent in anxious children under oral melatonin, intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years during local anaesthetic administration. |
1. To determine the efficacy of oral melatonin to intranasal midazolam
2. Efficacy of intranasal midazolam to nitrous oxide sedation
|
|
|
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)
|
09/07/2025 |
| 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="0" 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 - NO
|
|
Brief Summary
|
AIM- To comparatively evaluate the
efficacy of different premedication agent in anxious children under oral melatonin,
intranasal midazolam and nitrous oxide sedation in age group of 4 to 7 years
during local anaesthetic administration.
Material & Methodology- In a randomized study, 60
children with age group 4 to 7 with Frankl’s behavior rating scale 2 and 3,
received premedication, Group A- 3 mg/kg per dose of Oral melatonin 60 minute
before the procedure (n=20), Group B- 0.2 mg/kg intranasal midazolam 60 minute
before the local anaesthetic administration (n=20), Group C- preadjusted
mixture of nitrous oxide–oxygen sedation was administered in the concentration
of 30–70% using Matrx Porter Digital Relative analgesia machine (n-20).
Subjective
pain perception during injection was measured using Wong Baker Faces Pain
Rating Scale and objective pain by sound, eye, body movement rating scale and
Modified Dental Anxiety Scale score before and after local anaesthesia
administration, patient satisfaction and comfort levels scores. |