| CTRI Number |
CTRI/2019/09/021381 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
19/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two sedative agents in relation to safety in children. |
|
Scientific Title of Study
|
Comparison of intranasal midazolam and inhalation nitrous oxide sedation in relation to safety and physiological effects in children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neethu Ann Preethy |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28,Department of Pediatric and Preventive Dentistry,
Saveetha Dental college and hospitals,Chennai-600077,India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9715528833 |
| Fax |
|
| Email |
jesusisgreat.neethuann@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSujatha Somasundaram |
| Designation |
Reader |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Clinic 28,Department of Pediatric and Preventive Dentistry,
Saveetha Dental college and hospitals,Chennai-600077,India.
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
drsujatha.sdc865@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSujatha Somasundaram |
| Designation |
Reader |
| Affiliation |
Saveetha dental college and hospitals |
| Address |
Clinic 28,Department of Pediatric and Preventive Dentistry,
Saveetha Dental college and hospitals,Chennai-600077,India.
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
drsujatha.sdc865@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neethu Ann Preethy( self-funded) |
|
|
Primary Sponsor
|
| Name |
Neethu Ann Preethy |
| Address |
Clinic 28,Department of Pediatric and Preventive Dentistry,Saveetha Dental college and hospitals,162,poonamallee high road,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 |
| Neethu Ann Preethy |
Saveetha Dental college and hospitals. |
Clinic 28,Department of Pediatric and Preventive Dentistry,
Saveetha Dental college and hospitals,Chennai-600077,India.
Chennai
TAMIL NADU |
9715528833
jesusisgreat.neethuann@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inhalation nitrous oxide |
frequency : once from the start of procedure till the end of the procedure
Route: intranasal
Duration: depends on the duration of the dental treatment (e.g. 45 minutes) |
| Intervention |
intranasal midazolam |
frequency:once at the start of procedure
Route: intranasal
Duration: the effect prolongs for about 1-2 hours |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Anxious children requiring pulp therapy |
|
| ExclusionCriteria |
| Details |
respiratory disorders, previous medication with erythromycin and/or anticonvulsant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
onset of sedation
level of sedation
physiological parameters at different stages of the procedure
safety scale
recovery time |
Starting at the beginning of the sedation procedure till the end of the sedation procedure,vitals will be monitored- approximately 30 to 45 minutes depending on the severity of the case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery time |
at the end of the sedation procedure i.e., after 30 to 45 from the start of the procedure |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
29/09/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study uses intranasal midazolam which has a faster onset of action and immediate absorption as compared to oral midazolam.Midazolam was delivered with a mucosal atomisation device and nasal mask was used for nitrous oxide.
The safety of the procedure plays a vital role and thus both the drugs should be evaluated and compared based on the onset of sedation,level of sedation,safety scale,physiological parameters,recovery time and patient preference .This will help to derive proper knowledge and understanding on the physiological effect and safety for the proper use of the aforementioned drugs in future. |