NCT01361789

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Asker & Baerum Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery. The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.

Conditions

• Rupture of Anterior Cruciate Ligament

Interventions

Type	Name	Description
DRUG	parecoxib, valdecoxib, etoricoxib	40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery
DRUG	Dexamethasone	8 mg IV
DRUG	parecoxib, valdecoxib, parecoxib and dexamethasone	combination of both drugs

Timeline

• Start date: 2004-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2011-05-27
• Last updated: 2011-05-27

Locations

1 site across 1 country: Norway