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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  
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 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  
Status 
Not Applicable 
 
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.

 
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