| CTRI Number |
CTRI/2024/06/068626 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of spray in the nose in the reduction of swelling after the lower jaw wisdom tooth removal |
|
Scientific Title of Study
|
Efficacy of Intranasal Ketamine and Dexmedetomidine on Postoperative Pain and Swelling Following Impacted
Mandibular Third Molar Surgery
A Randomized Controlled Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandi Sreenivasulu |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.2,Block no.3, Department of Oral and Maxillofacial Surgery,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9063321966 |
| Fax |
|
| Email |
sreenivasulu.b@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Shivaji Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.2,Block no.3, Department of Oral and Maxillofacial Surgery,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9966351997 |
| Fax |
|
| Email |
shivajiraju.u@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Shivaji Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no.2,Block no.3, Department of Oral and Maxillofacial Surgery,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9966351997 |
| Fax |
|
| Email |
shivajiraju.u@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College
Vishnupur
Bhimavaram-534202,West Godavari District,AP |
|
|
Primary Sponsor
|
| Name |
Dr Bandi Sreenivasulu |
| Address |
Room no.2,Block no.3, Department of Oral and Maxillofacial Surgery
Vishnu Dental College
Vishnupur
Bhimavaram-534202,West Godavari,Andhra Pradesh |
| 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 Bandi Sreenivasulu |
Vishnu Dental College |
Room no.2, Block no.3, Department of Oral and Maxillofacial Surgery, Vishnu Dental College, Vishnupur
Bhimavaram-534202
West Godavari
ANDHRA PRADESH |
9063321966
sreenivasulu.b@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal dexmedetomidine |
1µg/kg of Dexmedetomidine will be given intranasally using mucosal atomization device(MAD)following surgical removal of impacted mandibular third molars |
| Intervention |
Intranasal ketamine |
0.2-1 mg/kg Ketamine will be given intranasally once using mucosal atomization device(MAD)following the surgical removal of impacted mandibular third molars
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with bilaterally similar impacted mandibular third molars
2. Systemically healthy patients, ASA class I & II
3.Patients willing to give an informed consent .
4. Patients not receiving any pain medication.
|
|
| ExclusionCriteria |
| Details |
1. Allergic to Ketamine and Dexmedetomidine
2. Patients not willing to give an informed consent
3. Acute inflammation or infection at the site of surgery
4. Allergic rhinitis, nasal pathologies
5. Pregnant and lactating women
6. Bradycardia
7. Renal or hepatic disease
8. Patients with a BMI of more than 27 kg/m2
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the reduction in Pain and Swelling after impacted mandibular third molar surgery
|
Reduction in Pain-1,6,12,24,48 hrs postoperatively.
Reduction in Swelling- 2nd and 7th postoperative day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
18/06/2024 |
| 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="6"
Days="1" |
|
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
|
The
aim of this study is to “Evaluate the effect of intranasal Ketamine and
intranasal Dexmedetomidine on Pain and Swelling in patients undergoing impacted
mandibular third molar surgery .â€To evaluate the clinical outcomes of intranasal Ketamine and intranasal
Dexmedetomidine on Pain, Swelling, Trismus after third molar surgery, to evaluate the sedative effect of intranasal Ketamine and
intranasal Dexmedetomidine during third molar surgery and to evaluate the effect on perioperative hemodynamic parameters like Blood pressure, Pulse rate, Respiratory rate
and Sp02. Inclusion criteria:Patients
of age 18 - 40 years, patients with bilaterally similar impacted mandibular
third molars, systemically
healthy patients, ASA class I & II, patients willing to give an informed consent, patients not receiving any pain
medication. Using
a split mouth study design ,bilaterally impacted third molars shall be removed
in two different appointments. [2 weeks]
|