Trial | NCT01361789  Report issue

Official Title

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    93
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.
Study Started
Jan 31
2004
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
May 27
2011
Estimate

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

COXIB Active Comparator

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

Dexamethasone Active Comparator

dexamethasone 8 mg iv

COXIB and dexamethasone Active Comparator

combination of coxib AND dexamethasone

Criteria 

Inclusion Criteria:

Arthroscopic reconstruction of the anterior crucial ligament (ACL)
At least 18 years old
ASA I + II

Exclusion Criteria:

Known renal impairment
Liver failure and/-or an asthmatic condition
Pregnancy
Breast feeding
No Results Posted