Evaluate Efficacy, Safety, and Tolerability of Intramuscular Etoricoxib vs Intravenous Paracetamol for Post-Operative Pain Management in Hip and Knee Arthroplasty Patients

A Post-Marketing, Investigator Initiated, Prospective, Single centre, Randomised, Open label, Two arm, Single dose, Parallel, Comparative Study to Evaluate Efficacy, Safety, and Tolerability of Intramuscular Etoricoxib vs Intravenous Paracetamol for Post-Operative Pain Management in Hip and Knee Arthroplasty Patients - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113503

Enrollment

100

Registered

2026-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: S709- Unspecified superficial injury ofhip and thigh

Interventions

Intervention1: Etoricoxib: The intramuscular formulation of Etoricoxib is provided as an injection containing a concentration of 90mg/ml. Paracetamol, provided as an intravenous injection containing 1

Eligibility

Inclusion criteria

Inclusion criteria: Participants must meet all the following inclusion criteria to be eligible for enrollment in the study: 1. Patients aged 18 years and older. 2. Patients who have undergone either hip or knee arthroplasty. 3. Patients who can provide informed consent, are willing to participate, and able to comply with the study protocol, including follow-up assessments.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have known allergy or hypersensitivity to the study drug, NSAIDs, or COX-2 inhibitors; a history of bronchospasm, rhinitis, angioedema, urticaria, or nasal polyps; cardiovascular disease; active peptic ulcer or gastrointestinal bleeding; renal or hepatic dysfunction; uncontrolled hypertension; inflammatory bowel disease; pregnancy or lactation; use of contraindicated medications; concurrent participation in another clinical study; or inability to comply with study procedures and follow-up requirements.

Design outcomes

Primary

Measure	Time frame
1. Time interval between study product administration and the first request for rescue opioid analgesia. [Time frame: From Enrolment to EOS]. 2. Cumulative amount of rescue opioid analgesic used per treatment arm. [Time frame: From Enrolment to EOS]. 3. NRS (Numeric Rating Scale) pain score; - - At rest (Time frame: During Screening and at each hour from Enrolment to EOS) At activity (Time frame: During physiotherapy post EnrolmentTimepoint: From Enrolment to EOS	—

Measure

Time frame

1. Time interval between study product administration and the first request for rescue opioid analgesia. [Time frame: From Enrolment to EOS]. 2. Cumulative amount of rescue opioid analgesic used per treatment arm. [Time frame: From Enrolment to EOS]. 3. NRS (Numeric Rating Scale) pain score; - - At rest (Time frame: During Screening and at each hour from Enrolment to EOS) At activity (Time frame: During physiotherapy post EnrolmentTimepoint: From Enrolment to EOS

—

Secondary

Measure	Time frame
1. Safety will be assessed based on number of adverse events [Time frame: From Screening to EOS]. 2. Tolerability will be assessed based on adverse events [Time frame: From Screening to EOS].Timepoint: From Screening to EOS	—

Countries

India

Contacts

Public ContactBrindha Arumugam

iDD Research Solutions Pvt. Ltd

yogesh@iddresearch.com8520082152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026