| CTRI Number |
CTRI/2025/07/091721 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Between the Injection Etoricoxib and Injection Diclofenac for Orthopedic Pain |
|
Scientific Title of Study
|
Efficacy and Safety of Intramuscular Etoricoxib vs Diclofenac Sodium Injections in the Management of Acute Orthopedic Pain - A Randomized Open Label Pilot Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S S PRAVIN |
| Designation |
PG Student |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of pharmacy practice, SRM college of Pharmacy,SRMIST,Kattankulathur,
Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
7010051101 |
| Fax |
|
| Email |
sspravin004@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Sarumathy |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of pharmacy practice, SRM college of Pharmacy,SRMIST,Kattankulathur,
Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
7010530419 |
| Fax |
|
| Email |
saruprabakar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Sarumathy |
| Designation |
Associate Professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of pharmacy practice, SRM college of Pharmacy,SRMIST,Kattankulathur,
Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
7010530419 |
| Fax |
|
| Email |
saruprabakar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM college of Pharmacy, SRM institute of science and technology, Kattankulathur, 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Collage of Pharmacy |
| Address |
SRM College of Pharmacy, Kattankulathur, Chenagalpattu, Tamil Nadu - 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Sarumathy |
SRM Medical College Hospital and Research Centre |
Department of Orthopedics, SRM Medical College Hospital and Research Centre, Chengalpattu Kancheepuram TAMIL NADU |
7010530419
saruprabakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Sodium 75 mg/ml IM OD (STAT) |
Group A - Etoricoxib 90 mg/ml IM OD(STAT) at 0,30,60min interval
Group B - Diclofenac Sodium 75 mg/ml IM OD (STAT) at 0,30,60min interval |
| Intervention |
Etoricoxib 90 mg/ml IM OD (STAT) |
Group A - Etoricoxib 90 mg/ml IM OD(STAT) at 0,30,60min interval
Group B - Diclofenac Sodium 75 mg/ml IM OD (STAT) at 0,30,60min interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with knee arthritis, fractures, back pain and back injury, muscle strain or sprain, torn ligament and also with the other orthopaedic inflammatory conditions |
|
| ExclusionCriteria |
| Details |
1. Patient with history of clinically significant cardiovascular diseases including hypertension, hepatic dysfunction, renal impairment, GI problems like peptic ulcer, GI bleeding of perforations and cerebrovascular issues.
2. Pregnancy and lactation.
3. Patients using drugs like NSAIDS, Diuretics, Anti coagulants, Rifampicin, Immunosuppressants, ACE inhibitors, ARBs, Lithium, Birth control pills and Digoxin
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain.
2. To identify the efficacy of IM etoricoxib over the Diclofenac at 30 minutes and 60 minutes using Visual Analog scale (VAS)
|
1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain.
2. To identify the efficacy of IM etoricoxib over the Diclofenac at 30 minutes and 60 minutes using Visual Analog scale (VAS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the safety of IM etoricoxib over the Diclofenac injections.
2. To assess for any allergic reactions or side effects.
3. To assess for the pain at the site of injection.
4. To identify the need for additional analgesia (rescue analgesia) along with an overall assessment of pain relief in IM etoricoxib injection versus Diclofenac.
5. Assess the pain at baseline 0min, 30min, 60min |
1. To assess the safety of IM etoricoxib over the Diclofenac injections.
2. To assess for any allergic reactions or side effects.
3. To assess for the pain at the site of injection.
4. To identify the need for additional analgesia (rescue analgesia) along with an overall assessment of pain relief in IM etoricoxib injection versus Diclofenac.
5. Assess the pain at baseline 0min, 30min, 60min |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
31/08/2025 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
India is shifting towards the phase of epidemiological transition where ageing and chronic disorders are at its peak which eventually results in the limitation of quality of life . The studies shows that the different range of orthopedic pain which is so common that it is reported by all age group of people during their period of life. In the year 2008, the esteemed Drug Controller General of India granted approval for the IM etoricoxib injection, formulated at a concentration of 90 mg per mL, to be administered for the alleviation of short-term acute painful conditions in adults.
Furthermore, IM injection can be particularly beneficial for patients who cannot tolerate or effectively absorb oral medications. As the global population ages, the prevalence of pain conditions, such as osteoarthritis, neuropathy, and other musculoskeletal disorders, is increasing, necessitating the frequent use of pain-relieving medications. pain-relieving medication, it is crucial to consider the potential misuse of these drugs. With this novel route of administration, the frequency of drug administration can be minimized, potentially reducing the cost of a single dose. COX-1-derived prostanoids are essential for ‘housekeeping ‘functions throughout the body and especially in the GI tract, kidney and platelets. PGE2 , for example, is recognised as an essential component for the maintenance of gastrointestinal mucosal integrity which it orchestrates by maintaining sub-mucosal blood flow, amongst other actions.
This study compares the efficacy and safety of intramuscular etoricoxib (90 mg/mL) versus diclofenac sodium (75 mg/mL) for managing acute orthopedic pain. It is a randomized, open-label pilot trial involving 70 patients aged 18-60 with conditions like fractures, arthritis, or sprains. Pain relief is measured using the Visual Analog Scale (VAS) at 30 and 60 minutes post-injection. The primary goal is to determine if etoricoxib provides faster or better pain relief than diclofenac, while secondary objectives assess safety and side effects. The study aims to establish IM etoricoxib as a viable alternative with fewer gastrointestinal risks compared to traditional NSAIDs like diclofenac. Ethical approvals and informed consent are secured.
This study has the primary goal to evaluate the safety and efficacy of IM etoricoxib and IM diclofenac sodium in patients with acute orthopaedic pain. To access the symptoms relief using pain scale based on the effect of treatment. |