Clinical Drug Investigation

, Volume 32, Issue 6, pp 361–371

Intranasal Ketorolac

For Short-Term Pain Management
Adis Drug Profile

Abstract

Ketorolac is a member of the pyrrolo-pyrrole group of NSAIDs, and has been available in several formulations for some time, for the treatment of pain. Intranasal ketorolac has recently become available.

Intranasal ketorolac was effective in providing short-term relief from postoperative pain in four well designed, phase II or III trials.

In the two phase III trials, a single intranasal dose of ketorolac 31.5 mg, with or without backup analgesia, was associated with significantly higher 6-hour summed post-treatment pain intensity difference scores (primary endpoint) than placebo in adult patients with acute pain following major surgery, including abdominal and orthopaedic surgery.

Intranasal ketorolac 31.5 mg up to three or four times daily for ≤5 days also had an opioid-sparing effect in these trials, with significantly less morphine used among ketorolac than among placebo recipients over the first 48 hours of treatment. Moreover, a greater proportion of ketorolac recipients experienced analgesia onset within 1 and 1.5 hours but not 2 hours than placebo recipients, indicating a more rapid onset with intranasal ketorolac.

In adult patients with acute pain following major surgery, intranasal ketorolac 31.5mg three or four times daily for ≤5 days was generally well tolerated. Most adverse events in clinical trials were considered to be of mild severity and transient in nature, with those in the phase III trials generally being characteristic of common events following major abdominal surgery and morphine administration.

References

  1. 1.
    Moore RA, Derry S, McQuay HJ, et al. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database Syst Rev 2011 Sep 7; 9: CD008659PubMedGoogle Scholar
  2. 2.
    Institute for Clinical Systems Improvement. Health care guideline: assessment and management of acute pain [online]. Available from URL: http://www.icsi.org/pain_acute/pain_acute_assessment_and_management_of_3.html [Accessed 2012 Jan 24]
  3. 3.
    Gillis JC, Brogden RN. Ketorolac. A reappraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic use in pain management. Drugs 1997 Jan; 53(1): 139–88PubMedCrossRefGoogle Scholar
  4. 4.
    McCormack PL. Ketorolac 0.45% ophthalmic solution. Drugs Aging 2011 Jul 1; 28(7): 583–9PubMedCrossRefGoogle Scholar
  5. 5.
    US FDA. SPRIX® (ketorolac tromethamine nasal spray) US prescribing information [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022382s000lbl.pdf [Accessed 2012 Mar 19]
  6. 6.
    Moodie JE, Brown CR, Bisley EJ, et al. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain [published erratum appears in Anesth Analg 2009; 108 (3): 991]. Anesth Analg 2008; 107(6): 2025–31PubMedCrossRefGoogle Scholar
  7. 7.
    McAleer SD, Majid O, Venables E, et al. Pharmacokinetics and safety of ketorolac following single intranasal and in-tramuscular administration in healthy volunteers. J Clin Pharmacol 2007; 47(1): 13–8PubMedCrossRefGoogle Scholar
  8. 8.
    Grant GM, Mehlisch DR. Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial. J Oral Maxillofac Surg 2010; 68(5): 1025–31PubMedCrossRefGoogle Scholar
  9. 9.
    Singla N, Singla S, Minkowitz HS, et al. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin 2010; 26(8): 1915–23PubMedCrossRefGoogle Scholar
  10. 10.
    Brown C, Moodie J, Bisley E, et al. Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study [published erratum appears in Pain Med 2011; 12: 990]. Pain Med 2009; 10(6): 1106–14PubMedCrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  1. 1.AdisAucklandNew Zealand

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