| 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
|
|
|
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
|
|
|
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
|
|
|
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. |