title: Parecoxib, propacetamol, and their combination for analgesia after total hip arthroplasty: a randomized non-inferiority trial.
abstract: BACKGROUND
  This study assessed non-inferiority of parecoxib vs. combination parecoxib+propacetamol and compared the opioid-sparing effects of parecoxib, propacetamol, and parecoxib+propacetamol vs. placebo after total hip arthroplasty.
  
  
  METHODS
  In this randomized, placebo-controlled, parallel-group, non-inferiority study, patients received one of four IV treatments after surgery: parecoxib 40 mg bid (n = 72); propacetamol 2 g qid (n = 71); parecoxib 40 mg bid plus propacetamol 2 g qid (n = 72); or placebo (n = 38) with supplemental IV patient-controlled analgesia (morphine). Patients and investigators were blinded to treatment. Pain intensity at rest and with movement was assessed regularly, together with functional recovery (modified Brief Pain Inventory-Short Form) and opioid-related side effects (Opioid-Related Symptom Distress Scale) questionnaires up to 48 h.
  
  
  RESULTS
  After 24 h, cumulative morphine consumption was reduced by 59.8% (P < 0.001), 38.9% (P < 0.001), and 26.8% (P = 0.005) in the parecoxib+propacetamol, parecoxib, and propacetamol groups, respectively, compared with placebo. Parecoxib did not meet criteria for non-inferiority to parecoxib+propacetamol. Parecoxib+propacetamol and parecoxib significantly reduced least-squares mean pain intensity scores at rest and with movement compared with propacetamol (P < 0.05). One day after surgery, parecoxib+propacetamol significantly reduced opioid-related symptom distress and decreased pain interference with function compared with propacetamol or placebo.
  
  
  CONCLUSIONS
  Parecoxib and parecoxib+propacetamol provided significant opioid-sparing efficacy compared with placebo; non-inferiority of parecoxib to parecoxib+propacetamol was not demonstrated. Opioid-sparing efficacy was accompanied by significant reductions in pain intensity on movement, improved functional outcome, and less opioid-related symptom distress. Study medications were well tolerated.
authors.affiliation: Department of Anesthesiology, University of Brussels, Brussels, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Camu
authors.affiliation: Department of Anesthesiology, Uniklinik Balgrist, Zurich, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: Borgeat
authors.affiliation: Department of Anesthesia, Intensive Care, Emergency Care and the Multidisciplinary Pain Centre, Ziekenhuis Oost-Limburg, Genk, Belgium.
authors.forename: R J
authors.initials: RJ
authors.lastname: Heylen
authors.affiliation: Department Anesthesiology-Intensive Care, Emergency Medicine and Pain Management, Pain Clinic, Regional University Hospital Caremeau Nîmes and Faculty of Medicine of Montpellier-Nîmes, Montpellier-Nîmes, France.
authors.forename: E J
authors.initials: EJ
authors.lastname: Viel
authors.affiliation: Outcomes Research, Pfizer Inc, Ann Arbor, MI, USA.
authors.forename: M E
authors.initials: ME
authors.lastname: Boye
authors.affiliation: Global Medical Team, Pfizer Inc, New York, NY, USA.
authors.forename: R Y
authors.initials: RY
authors.lastname: Cheung
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016058:Analgesia, Patient-Controlled; D019644:Arthroplasty, Replacement, Hip; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D020127:Recovery of Function
chemical_list: D007555:Isoxazoles; D000082:Acetaminophen; C063776:propacetamol; D009020:Morphine; C409945:parecoxib