Zusammenfassung
Fragestellung
Wie wirksam ist eine präoperative Gabe des Cyclooxygenase-2-Hemmers Rofecoxib in einer Dosis von 25 mg bei kleineren kniegelenknahen Operationen?
Methodik
31 Patienten erhielten 2 h präoperativ sowie nach 24 h jeweils 25 mg Rofecoxib oral (Verumgruppe), eine Kontrollgruppe von ebenfalls 31 Patienten ein gleichaussehendes Placebopräparat. Nach einer Operation an der unteren Extremität erhielten alle Patienten ein patientenkontrolliertes Analgesie-(PCA-)Gerät, mit dem sie sich intravenös Piritramid anfordern konnten. Sie waren angewiesen, sich auf ein gut erträgliches Schmerzniveau auf der numerischen Ratingskala (NRS) von 3 (0–10) zu titrieren. Erfasst wurden über 24 h der kumulative Piritramidverbrauch, die Schmerzscores der Patienten sowie Nebenwirkungen.
Ergebnisse
Beide Gruppen hatten zu allen Erhebungszeitpunkten vergleichbare Schmerzscores. Die Patienten der Verumgruppe forderten exakt die gleiche Menge Piritramid aus dem PCA-Gerät an wie die Patienten der Placebogruppe.
Schlussfolgerungen
Die präoperative Gabe von 25 mg Rofecoxib hat nach dem Ergebnis der vorliegenden Studie auch bei kleineren muskuloskelettalen Operationen keinen analgetischen Effekt.
Abstract
Objective
The purpose of this study was to evaluate the analgesic efficacy of 25 mg rofecoxib.
Methods
In a randomized, prospective double-blind study we investigated the analgesic efficacy of 25 mg rofecoxib in 62 patients scheduled for minor trauma surgery. Patients received 2 h before induction of anesthesia either 25 mg rofecoxib (verum) orally or placebo. These applications were repeated postoperatively after 24 h. Postoperative pain intensity was measured by the numeric rating scale (NRS). All patients were allowed to order piritramid from a PCA-device (bolus 2 mg, lockout 5 min in the recovery room, 15 min on the ward) for 24 h after surgery. 10/20/30 min, as well as 1/2/4/6 h and 24 h after surgery cumulated doses of piritramid, pain scores (0–10) and side effects were recorded.
Results
Pain relief and cumulated doses of piritramid in both groups were comparable at all points in time. There were no significant differences in the incidence of side effects between the two groups.
Conclusion
Preoperative application of 25 mg rofecoxib is not effective for postoperative analgesia in patients after minor trauma surgery.
Literatur
Amrein PC, Ellman LHWH (1981) Aspirin-induced prolongation of bleeding time and perioperative blood loss. J Am Med Assoc 245:1825–1828
Barden J, Edwards JE, McQuay HJ, Moore RA (2002) Single-dose rofecoxib for acute postoperative pain in adults: a quantitative systematic review. BMC Anesthesiol 2:4–18
Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. New Engl J Med 23:1520–1528
Chang DJ, Desjardins PJ, Chen E, Polis AB, Mcavoy M, Mockoviak SH, Geba GP (2002) Comparison of the analgesic efficacy of rofecoxib and enteric-coated diclofenac sodium in the treatment of postoperative dental pain: a randomized, placebo-controlled clinical trial. Clin Ther 24(4):490–503
Chang DJ, Fricke JR, Bird SR, Bohidar NR, Dobbins TW, Geba GP (2001) Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial. Clin Ther 23:1446–1455
Day R, Morrison B, Luza A, Castaneda O, Strusberg A, Nahir M, Helgetveit KB, Kress B, Daniels B, Bolognese J, Krupa D, Seidenberg B, Ehrich E (2000) A randomized trial of the efficacy and tolerability of the cox-2 inhibitor rofecoxib vs. ibuprofen in patients with osteoarthritis. Arch Intern Med 160:1781–1787
Ehrich EW, Dallob A, De Lepeleire I, Van Hecken A, Riendeau D, Yuan W, Porras A, Wittreich J, Seibold JR, De Schepper P, Mehlisch DR, Gertz BJ (1999) Characterization of rofecoxib as a cyclooxygenase-2 isoform ihibitor and demonstration of analgesia in the dental pain model. Clin Pharmacol Ther 65:336–347
Fauno P, Petersen KD, Husted SE (1993) Increased blood loss after preoperative NSAID. Acta Orthopaed Scand 64(5):522–524
Geisslinger G, Peskar BA, Pallapies D, Sittl R, Levy M, Brune K (1996) The effects on platelet aggregation and prostanoid biosynthesis of two parenteral analgesics: ketorolac tromethamine and dipyrone. Thromb Haemost 76(4):592–597
Hawkey CJ (1999) COX-2 inhibitors. Lancet 353:307–314
Heinzl S (2000) Rofecoxib. Zielgerichteter COX-2-Hemmer zur Behandlung der Arthrose in Deutschland zugelassen. Arzneimitteltherapie 47 [suppl]:1–4
Joshi W, Connelly NR, Reuben SS, Wolkenhaar M, Thakkar N (2003) An evaluation of the safety and efficacy of administering rofecoxib for postoperative pain management. Anesth Analg 97(1):35–38
Lawrence C, Sakuntabhai A, Tiling-Grosse S (1994) Effect of aspirin and nonsteroidal antiinflammatory drug therapy on bleeding complications in dermatologic surgical patients. J Am Acad Dermatol 31(6):988–992
Leese PT, Hubbard RC, Karim A (2000) Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: a randomized, controlled trial. J Clin Pharmacol
Marret E, Flahault A, Samama CM, Bonnet F (2003) Effects of postoperative, nonsteroidal, antiinflammatory drugs on bleeding risk after tonsillectomy: meta-analysis of randomized, controlled trials. Anesthesiology 98(6):1497–1502
Morrison BW, Christensen S, Yuan W, Brown J, Amlani S, Seidenberg B (1999) Analgesic efficacy of the cyclooxygenase-2-specific inibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther 21:943–953
Morrison BW, Fricke J, Brown J, Yuan W, Kotey P, Mehlisch D (2000) The optimal analgesic dose of rofecoxib: overwiew of six randomized controlled trials. JADA 131:1729–1737
Pallapies D, Peskar BA, Brune K, Geisslinger G (1994) Effects on platelet functions and pharmacokinetics of azapropazone and ketorolac tromethamine given as single parenteral doses. Br J Clin Pharmacol 37:335–339
Pickering AE, Bridge HS, Nolan J, Stoddart PA (2002) Double-blind, placebo-controlled analgesic study of ibuprofen or rofecoxib in combination with paracetamol for tonsillectomy in children. Br J Anaesth 88:72–77
Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR (2002) COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 360(9339):1071–1073
Reicin A, Brown J, Jove M, deAndrade JR, Bourne M, Krupa D, Walters D, Seidenberg B (2001) Efficacy of single-dose and multidose rofecoxib in the treatment of post-orthopedic surgery pain. Am J Orthop 30:40–48
Reuben SS, Bhoptkar S, Maciolek H, Joshi W, Sklar D, Sklar J (2002) The preemptive analgesic effect of rofecoxib after ambulatory arthroscopic knee surgery. Anesth Analg 94:55–59
Reuben SS, Connelly NR (2000) Postoperative analgesic effects of celecoxib and rofecoxib after spinal fusion surgery. Anesth Analg 91:1221–1225
Saag K, van der Heijde D, Fisher C, Smara A, De Tora L, Bolognese J, Sperling R, Daniels B (2000) Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugs. Arch Fam Med 9:1124–1134
Schafer AI (1999) Effects of nonsteroidal anti-inflammatory therapy on platelets. Am J Med 106:25S–35S
Shen Q, Sinatra R, Luther M, Halaszynski T (2001) Preoperative rofecoxib 25 mg and 50 mg: effects on post-surgical morphin consumption and effort dependent pain. Anesthesiology 95:A961 (abstr)
Steffen P, Drück A, Krinn E, Möller A, Georgieff M, Seeling W (1996) Untersuchungen zum differenzierten Einsatz von Nichtopioiden zur postoperativen Analgesie II: Quantifizierung des analgetischen Effektes der Kombination von Metamizol plus Diclofenac mittels der patientenkontrollierten Analgesie. Anesthesiol Intensivmed Notfallmed Schmerzther 31:216–221
Steffen P, Krinn E, Möller A, Seeling W, Rockemann M (2002) Metamizol and diclofenac profoundly reduce opioid consumption after minor trauma surgery. Acute Pain 4:71–75
Steffen P, Opderbeck S, Seeling W (1993) Reduktion des postoperativen Opioidbedarfs durch die perioperative Gabe von Naproxen. Schmerz 7:167–173
Steffen P, Schuhmacher I, Weichel T, Georgieff M, Seeling W (1996) Untersuchungen zum differenzierten Einsatz von Nichtopioiden zur postoperativen Analgesie I: Quantifizierung des analgetischen Effektes von Metamizol mittels der patientenkontrollierten Analgesie. Anesthesiol Intensivmed Notfallmed Schmerzther 31:143–147
Steffen P, Seeling W, Reiser A, Rockemann M, Georgieff M (1997) Untersuchungen zum differenzierten Einsatz von Nichtopioiden zur postoperativen Analgesie III: Analgetischer Effekt einer perioperativen Gabe von Metamizol puls Diclofenac nach Spinalanästhesien. Anesthesiol Intensivmed Notfallmed Schmerzther 32:496–501
Steffen P, Wiedemann S, Georgieff M, Hähnel J, Treiber H, Seeling W (1994) Kombinierte intravenöse Gabe von Diclofenac und Azapropazon zur postoperativen Analgesie. Schmerz 8:235–242
Turan A, Emet S, Karamanlioglu B, Memis D, Turan N, Pamukcu Z (2002) Analgesic effects of rofecoxib in ear-nose-throat surgery. Anesth Analg 95(59:1308–1311
Interessenkonflikt:
Keine Angaben
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Steffen, P., Krell, M. & Seeling, W. Perioperative Schmerztherapie mit Rofecoxib. Schmerz 18, 278–285 (2004). https://doi.org/10.1007/s00482-003-0304-0
Issue Date:
DOI: https://doi.org/10.1007/s00482-003-0304-0