COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Sponsor

Asker & Baerum Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01361789

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rupture of Anterior Cruciate Ligament	Drug: parecoxib, valdecoxib, etoricoxib Drug: Dexamethasone Drug: parecoxib, valdecoxib, parecoxib and dexamethasone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: COXIB 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: 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
Active Comparator: Dexamethasone dexamethasone 8 mg iv	Drug: Dexamethasone 8 mg IV
Active Comparator: COXIB and dexamethasone combination of coxib AND dexamethasone	Drug: parecoxib, valdecoxib, parecoxib and dexamethasone combination of both drugs

Arm

Intervention/Treatment

Active Comparator: COXIB

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: parecoxib, valdecoxib, etoricoxib

Active Comparator: Dexamethasone

dexamethasone 8 mg iv

Drug: Dexamethasone

8 mg IV

Active Comparator: COXIB and dexamethasone

combination of coxib AND dexamethasone

Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

combination of both drugs