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Comparisons of Parenteral and Enteral COX-2 inhibitors for Post-operative pain of TKA, a prospective non-inferiority randomized double-blinded controlled trial

Comparisons of Parenteral and Enteral COX-2 inhibitors for Post-operative pain of TKA, a prospective non-inferiority randomized double-blinded controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180618002
Enrollment
80
Registered
2018-06-18
Start date
2018-06-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

none Parecoxib&#44

Interventions

&#45
Parecoxib 40 mg IV q 12 hour total 4 doses &#45
Placebo 1 capsule q 12 hours total 4 doses *** Placebo = Empty celebrex capsule ***, &#45
Celecoxib 200 mg po q 12 hour total 4 doses &#45
0.9% NSS 2 ml IV q 12 hour total 4 doses
Active Comparator Drug,Active Comparator Drug
Parecoxib groups,Celecoxib groups

Sponsors

Songklanagarind hospital prince of songkla university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who is primary osteoarthritis had failed conservative treatment and decided to undergo Total knee surgery. 2. Age over 55 years

Exclusion criteria

Exclusion criteria: 1. Research participants who had allergy to paracetamol&#44; Aspirin&#44; Sulfonamide drug or NSAIDs(Celecoxib or Parecoxib)&#44; Opioids 2. Research participants who had Peptic ulcer disease or Inflammatory bowel disease 3. Research participants who had Chronic rheumatoid arthritis 4. Research participants who had Chronic kidney disease[eGFR < 60 mL/min/1.73m2] 5. Research participants who had Heart ischemia 6. Research participants who had Stoke or brain ischemia 7. Research participants who had Primary or seconary cancer 8. Research participants who had Psychotic disease 9. Research participants who had Asthma or Bronchospasm with treat Steroid 10. Research participantsvwho had cognitive impairment 11. Research participants who had American Society of Anesthesiologists (ASA) grade 4–5 12. Research participants were unable to communicate and cooperate with the researcher. 13. Research participants who had under spinal block anesthesia .

Design outcomes

Primary

MeasureTime frame
Pain 6 hour&#44; 12hour &#44; 24 hours and 48 hours after TKA Pain score

Secondary

MeasureTime frame
Fentanyl comsumption 24 hours and 48 hours total doses of Fentanyl,Nausea and Vomitting 48 hours number of times,Blood loss 6 hours after surgery milliliter ; modification of the Gross formula,Creatinine Post&#45;op day 3 mg/dL,Creatinine Post&#45;op day 3 mg/dL,ROM of knee Post&#45;op day 1 &#44; Post&#45;op day 2 Goniometer&#44; degrees,Time to walk Still stay hospital hours,Hospital stay When patient is discharge hours,Knee and Osteoarthritis Outcome Score(KOOS) F/U 2 wks &#44; 6 wks after surgery score

Countries

Thailand

Contacts

Public ContactKhanin Iamthanaporn

Orthopedic department&#44; Songklanagarind hospital

khanin.i@psu.ac.th081-555-8362

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026