A Comparative Study Between the Injection Etoricoxib and Injection Diclofenac for Orthopedic Pain

Efficacy and Safety of Intramuscular Etoricoxib vs Diclofenac Sodium Injections in the Management of Acute Orthopedic Pain - A Randomized Open Label Pilot Study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091721

Enrollment

Registered

2025-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R52- Pain, unspecified

Interventions

Intervention1: 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 Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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) Timepoint: 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)	—

Measure

Time frame

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) Timepoint: 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)

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Secondary

Measure	Time frame
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, 60minTimepoint: 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	—

Measure

Time frame

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, 60minTimepoint: 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

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Countries

India

Contacts

Public ContactDr S Sarumathy

SRM College of Pharmacy

saruprabakar@gmail.com7010530419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026