| CTRI Number |
CTRI/2025/02/080613 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
efficacy of inhalational , intranasal and oral sedatives in managing behaviour of pediatric dental patients: a randomized controlled trial |
|
Scientific Title of Study
|
COMPARISON OF THE EFFICACY OF INHALATIONAL, INTRANASAL
AND ORAL SEDATIVES IN PEDIATRIC DENTAL PATIENT MANAGEMENT: 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 Aanchal Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Subharti dental college and hospital , Swami Vivekananda Subharti University
Meerut
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9084727563 |
| Fax |
|
| Email |
aanchalsingh06666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Srivastva |
| Designation |
Principal and Head Department of Pediatric & Preventive Dentistry |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Subharti dental college and hospital , Swami Vivekananda Subharti University
Meerut
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639000645 |
| Fax |
|
| Email |
drnikhilpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Srivastva |
| Designation |
Principal and Head Department of Pediatric & Preventive Dentistry |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Subharti dental college and hospital , Swami Vivekananda Subharti University
Meerut
UTTAR PRADESH
250005
India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639000645 |
| Fax |
|
| Email |
drnikhilpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital , Swami Vivekanand Subharti University , NH-58,Delhi-Haridwar Bypass Road |
|
|
Primary Sponsor
|
| Name |
Dr Aanchal Singh |
| Address |
Subharti Dental College and Hospital , Swami Vivekanand Subharti University Subharti Puram, NH-58, Delhi Haridwar, NH58, Meerut, Uttar Pradesh 250005,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 Aanchal Singh |
Dr Aanchal Singh |
Department of Pediatric and Preventive Dentistry,1st floor, Subharti dental college and hospital , Swami Vivekananda Subharti University, NH-58 , Delhi-Haridwar Bypass Road
Meerut 250005 india
UTTAR PRADESH
Meerut
UTTAR PRADESH |
9084727563
aanchalsingh06666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical, Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children who require a dental procedure under local anesthesia |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRANASAL MIDAZOLAM SEDATION |
Baseline vital values will be established with pulse oximeter.
Intranasal midazolam dose: 0.2mg/kg administered using
INSED atomizer (5mg/ml) will be given to the patient.
Exact dose will be calculated based on patient weight.
Time of drug administration will be noted.
Sedation level, behaviour and pain perception will be assessed. |
| Comparator Agent |
NITROUS OXIDE -OXYGEN SEDATION |
Baseline vitals will be established before induction.
Initial administration: 100% oxygen for 2-3 minutes to determine
flow rate of 5-6 L/ml will be done.
Titrated nitrous oxide-oxygen mixture will be administered and
maintained.
Sedation level, behaviour and pain perception will be assessed.
Termination will be done by giving 100% oxygen administered
for 5 minutes. |
| Intervention |
TRICLOFOS ORAL SOLUTION (PEDICLORYL) |
Baseline vitals established with pulse oximeter.
70mg/kg triclofos oral solution (Pedicloryl 500mg/5ml) will be
given orally.
Dosage will be calculated based on patient weight.
Time of drug administration will be noted.
Sedation level, behaviour and pain perception will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Anxious children aged between 4-8 years.
Children having a physical status of ASA I according to the
American Society of Anaesthesiologists.
Children having Frankl behaviour rating scale- positive.
Children who require a dental procedure under local anaesthesia.
Fasting status of children – light meal 2 hours before undergoing
dental procedure. |
|
| ExclusionCriteria |
| Details |
Very uncooperative children (frankl behaviour rating – definitive
negative) .
Children who recently used medications like erythromycin or
anticonvulsants
that may interfere with the pharmacokinetics of midazolam.
Children with known hypersensitivity to nitrous oxide -oxigen
sedation, intranasal midazolam and triclofos.
Children with any systemic disease and special health care needs.
Children with any condition that predisposes them to airway
obstruction or difficulties (eg COPD, allergic rhinitis, adenoid
hyperplasia, nasal septum problems, enlarged turbinates or nasal
polyp).
Children with upper or lower respiratory tract infections. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of sedation of the patient will be assessed by Modified
Ramsay sedation sale.
pain perception will be assessed by using wong-baker faces pain
rating scale.
|
immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
overall behaniour will be asses by using Houpt Sedation Rating
Scale. |
immediate |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/02/2025 |
| 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="1"
Months="0"
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
|
Dental fear significantly impacts pediatric dentistry, with prevalence ranging from 5.7% to 19.5%, often deterring children from regular visits and increasing oral health risks. Addressing dental anxiety is crucial to improving immediate care and preventing long-term oral health issues. Non-pharmacological methods like Tell-Show-Do, distraction, and cognitive-behavioral therapy (CBT) are effective, while pharmacological options, including sedation, are necessary for some patients. Conscious sedation, using agents like midazolam, triclofos, and nitrous oxide, plays a key role in managing dental anxiety. Each sedation method has distinct benefits, with nitrous oxide offering rapid onset and recovery, intranasal midazolam providing effective anxiolysis, and triclofos acting as an oral sedative. However, limited randomized clinical trials compare their efficacy. This study aims to evaluate the sedative effectiveness of nitrous oxide, intranasal midazolam, and oral triclofos in pediatric dental patients
|