Clinical Drug Investigation

, Volume 11, Supplement 1, pp 15–21 | Cite as

Comparative Efficacy of Oral Ibuprofen Arginine and Intramuscular Ketorolac in Patients with Postcaesarean Section Pain

  • Brunella Pagnoni
  • M. Vignali
  • S. Colella
  • R. Monopoli
  • M. Tiengo


In this double-blind double-dummy placebo-controlled study. 92 patients from a single centre were randomly assigned to receive either ibuprofen arginine 400mg orally, ketorolac 30mg by intramuscular injection, or placebo, after caesarean section. Pain intensity was measured on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100mm (unbearable pain) at 15, 30, 45, 60. 90, 120, 180, 240, 300, and 360 minutes after the administration of study medication.

Pain intensity was reduced in both active treatment groups from mean levels of 78mm (ibuprofen arginine treatment group) and 81mm (ketorolac group) to 47 and 48mm, respectively, stabilising at ≤ 50mm after the first hour. In contrast, pain levels in the placebo group (78mm) were reduced to 63mm within the first hour after medication administration, then climbed slightly to stabilise at a mean level of approximately 69mm on the VAS. Statistically significant differences were observed between active treatment groups and placebo, but not between the ketorolac and ibuprofen arginine treatment groups.

47% of patients in the ibuprofen arginine treatment group rated their medication as good or better, compared with 53% of ketorolac recipients and 12% of placebo recipients. 66% of patients receiving placebo required rescue medication, compared with 43% and 37% of patients receiving ibuprofen arginine and ketorolac, respectively. No adverse effects were reported.

These findings suggest that oral administration of ibuprofen arginine may prove to be a useful alternative to parenteral administration of analgesic agents in the immediate postoperative period after caesarean section.


Visual Analogue Scale Caesarean Section Ibuprofen Pain Intensity Visual Analogue Scale Score 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Owen H, Glavin RJ, Shaw NA. Ibuprofen in the management of postoperative pain. Br J Anaesth 1986; 58: 1371–5PubMedCrossRefGoogle Scholar
  2. 2.
    Beaver WT. Impact of non-narcotic oral analgesics on pain management. Am J Med 1988; 84: 3–15PubMedCrossRefGoogle Scholar
  3. 3.
    Cashman J, McAnulty G. Nonsteroidal anti-inflammatory drugs in perisurgical pain management. Drugs 1995; 49: 51–70PubMedCrossRefGoogle Scholar
  4. 4.
    Rodriguez LAG, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal antiinflammatory drugs. Lancet 1994; 343: 769–72CrossRefGoogle Scholar
  5. 5.
    Ceppi-Monti N, Gazzaniga A, Gianesello V, et al. Activity and pharmacokinetics of a new oral dosage form of soluble ibuprofen. Arzneimittelforschung 1992; 42(4): 556–9PubMedGoogle Scholar
  6. 6.
    Buckley MM-T, Brogden RN. Ketorolac: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs 1990; 39(1): 86–109PubMedCrossRefGoogle Scholar
  7. 7.
    CPMP Working Party On Efficacy of Medicinal Products. EEC note for guidance: good clinical practice for trials of medicinal products in the European Community. Pharmacol Toxicol 1990; 67(4): 361–72CrossRefGoogle Scholar
  8. 8.
    Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the visual analogue scale. Fam Pract Res J 1993; 13: 15–24PubMedGoogle Scholar
  9. 9.
    Varassi G, Capogna G, Celleno D, DeNicola A. Dolore postoperatorio in ostetrica. Minerva Anesth 1990; 56(7–8): 365–7Google Scholar
  10. 10.
    Ostensen M, Husby G. Antirheumatic drug treatment during pregnancy and lactation. Scand J Rheumatol 1985; 14: 1–7PubMedCrossRefGoogle Scholar
  11. 11.
    Mcintosh DG, Rayburn WF. Patient-controlled analgesia in obstetrics and gynecology. Obstet Gynecol 1991; 78(6): 1129–35PubMedGoogle Scholar

Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • Brunella Pagnoni
    • 1
  • M. Vignali
    • 1
  • S. Colella
    • 2
  • R. Monopoli
    • 2
  • M. Tiengo
    • 1
  1. 1.Primario F.F, Servizio di Anestesia e RianimazioneIstituto di Clinica Ostetrica e Ginecologica MangiagalliMilanItaly
  2. 2.Corporate Medical DepartmentZambon Group SpABresso, MilanItaly

Personalised recommendations