title: Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial.
abstract: BACKGROUND
  This multi-centre, prospective, randomized, double-blind, placebo-controlled study was designed to test the hypotheses that parecoxib improves patients' postoperative analgesia without increasing surgical blood loss following radical open prostatectomy.
  
  
  METHODS
  105 patients (64 ± 7 years old) were randomized to receive either parecoxib or placebo with concurrent morphine patient controlled analgesia. Cumulative opioid consumption (primary objective) and the overall benefit of analgesia score (OBAS), the modified brief pain inventory short form (m-BPI-sf), the opioid-related symptom distress scale (OR-SDS), and perioperative blood loss (secondary objectives) were assessed.
  
  
  RESULTS
  In each group 48 patients received the study medication for 48 hours postoperatively. Parecoxib significantly reduced cumulative opioid consumption by 24% (43 ± 24.1 mg versus 57 ± 28 mg, mean ± SD, p=0.02), translating into improved benefit of analgesia (OBAS: 2(0/4) versus 3(1/5.25), p=0.01), pain severity (m-BPI-sf: 1(1/2) versus 2(2/3), p < 0.01) and pain interference (m-BPI-sf: 1(0/1) versus 1(1/3), p=0.001), as well as reduced opioid-related side effects (OR-SDS score: 0.3(0.075/0.51) versus 0.4(0.2/0.83), p=0.03). Blood loss was significantly higher at 24 hours following surgery in the parecoxib group (4.3 g⋅dL(-1) (3.6/4.9) versus (3.2 g⋅dL(-1) (2.4/4.95), p=0.02).
  
  
  CONCLUSIONS
  Following major abdominal surgery, parecoxib significantly improves patients' perceived analgesia. Parecoxib may however increase perioperative blood loss. Further trials are needed to evaluate the effects of selective cyclooxygenase-2 inhibitors on blood loss.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00346268.
authors.affiliation: Klinik für Anästhesiologie und Intensivmedizin, Universität Duisburg-Essen, Universitätsklinikum Essen, Hufelandstrasse 55, Essen, D-45144 Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dirkmann
authors.affiliation: Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Kliniken Essen Mitte, Henricistrasse 92, Essen, 45136 Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Groeben
authors.affiliation: Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 USA.
authors.forename: Hassan
authors.initials: H
authors.lastname: Farhan
authors.affiliation: Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Stahl
authors.affiliation: Klinik für Anästhesiologie und Intensivmedizin, Universität Duisburg-Essen, Universitätsklinikum Essen, Hufelandstrasse 55, Essen, D-45144 Germany ; Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 USA.
authors.forename: Matthias
authors.initials: M
authors.lastname: Eikermann
mesh_terms: D016058:Analgesia, Patient-Controlled / Q000523:psychology; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000009:adverse effects / Q000627:therapeutic use; D059408:Pain Management; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000523:psychology; D017060:Patient Satisfaction; D019106:Postoperative Hemorrhage / Q000139:chemically induced*; D011468:Prostatectomy / Q000009:adverse effects*
chemical_list: D000701:Analgesics, Opioid; D052246:Cyclooxygenase 2 Inhibitors; D007555:Isoxazoles; D009020:Morphine; C409945:parecoxib
keywords: Analgesics non-opioids; Analgesics opioids; Morphine; Pain; Parecoxib; Postoperative pain