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CTRI Number  CTRI/2024/11/077104 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oral Preemptive analgesic efficacy in post operative pain , nausea and vomiting in third molar removal surgery - A Randomised control clinical trial 
Scientific Title of Study   Oral Preemptive analgesic efficacy in post operative pain , nausea and vomiting in third molar removal surgery - A Randomised control clinical 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  Sunil Yesvanthu S V 
Designation  PG Resident  
Affiliation  Saveetha Dental College and Hospital ,SIMATS 
Address  Clinic 20, 162, Poonamallee High Road, Velappanchavadi,

Chennai
TAMIL NADU
600077
India 
Phone  8778834861  
Fax    
Email  152304004.sdc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunil Yesvanthu S V 
Designation  PG Resident  
Affiliation  Saveetha Dental College and Hospital ,SIMATS 
Address  162, Poonamallee High Road, Velappanchavadi,


TAMIL NADU
600077
India 
Phone  8778834861  
Fax    
Email  152304004.sdc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sunil Yesvanthu S V 
Designation  PG Resident  
Affiliation  Saveetha Dental College and Hospital ,SIMATS 
Address  162, Poonamallee High Road, Velappanchavadi,


TAMIL NADU
600077
India 
Phone  8778834861  
Fax    
Email  152304004.sdc@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  SUURYA KALAA MAKKALL NALANN MARUNDHAGHAM 
Address  424, Mysore Trunk Rd, near MARS TVS SHOWROOM, RANGASMUDHRAM, Sathyamangalam, Tamil Nadu 638402 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Yesvanthu   Saveetha Dental College and Hospital   162, Poonamallee High Road, Velappanchavadi,
Chennai
TAMIL NADU 
8778834861

152304004.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee (SDC-9HEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Conscious, oriented and stable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Analgesic agent   Tablet Aceclofenac + Paractemol and serratiopeptidase 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients requiring surgical removal of impacted teeth in mandible following by inferior alveolar nerve block  
 
ExclusionCriteria 
Details  Patient already on analgesics medication, children, patients with peri apical pathology and special care patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain , nausea and vomiting .  Post operative pain , nausea and vomiting . 
 
Secondary Outcome  
Outcome  TimePoints 
Patient’s comfort and general condition post operatively  Patient’s comfort and general condition post operatively 
 
Target Sample Size   Total Sample Size="129"
Sample Size from India="129" 
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/ Phase 3 
Date of First Enrollment (India)   20/12/2024 
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="0"
Months="6"
Days="4" 
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  

**Summary**


**Background**: Postoperative pain, nausea, and vomiting (PONV) are common complications following third molar (wisdom tooth) extraction, often necessitating effective pain management strategies. Oral preemptive analgesia, administered before surgery, is hypothesized to reduce these postoperative symptoms by mitigating the central sensitization associated with surgical trauma.


**Objective**: This randomized controlled clinical trial aimed to evaluate the efficacy of oral preemptive analgesia in reducing postoperative pain, nausea, and vomiting following third molar extraction.


**Methods**: A total of 129 participants, aged between 18 and 35 years, who required the surgical removal of impacted third molars, were recruited and randomly assigned into two groups. Group A (n=65) received a single dose of oral preemptive analgesic 30 minutes before surgery, while Group B (n=64) received a placebo. Postoperative pain levels were assessed using the Visual Analog Scale (VAS) at 6,12 and 24 hours post-surgery. The incidence and severity of nausea and vomiting were recorded using the Numeric Rating Scale (NRS) and monitored over a 24-hour period postoperatively.


**Results**: Group A reported significantly lower VAS pain scores compared to Group B at 6, 12, and 24 hours post-surgery (p<0.05). The incidence of nausea and vomiting was also markedly reduced in Group A, with fewer participants requiring rescue antiemetics compared to Group B (p<0.05). Additionally, participants in Group A demonstrated a quicker return to normal activities.


**Conclusion**: Preemptive oral analgesia significantly reduced postoperative pain and the incidence of nausea and vomiting following third molar surgery. This strategy could improve patient comfort and recovery, suggesting its utility as part of routine perioperative management in oral surgery.

 
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