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Ketorolac
See also Non-steroidal anti-inflammatory drugs (NSAIDs)
General information
Ketorolac is a pyrrolizine carboxylic acid derivative, structurally and pharmacologically related to tolmetin, zomepirac, and indometacin. The trometamol salt of ketorolac enhances its solubility and allows parenteral administration.
Opinions on the safety of ketorolac in EC drug regulatory authorities are conflicting [ ]. However, the risk of adverse reactions is higher when ketorolac is used in higher doses, in elderly subjects, and for more than 5 days [ ].
Other information on the benefit-to-harm balance of parenteral ketorolac trometamine as a postoperative analgesic has been provided by three studies [ ]. The overall risk of gastrointestinal and operative site bleeding and acute renal insufficiency associated with parenteral ketorolac and a parenteral opioid were relatively small.
The most commonly reported symptoms are somnolence, headache, dizziness, nausea, dyspepsia, and abdominal pain; edema, hyperkalemia, diarrhea, sweating, self-limiting wheezing, and itching have also been reported occasionally [ ].
A regulatory review of ketorolac in many countries led to revision of the label, dosage recommendations, and prescribing practices. Ketorolac should be limited in dosage and duration; in elderly patients it should probably not be used at all. Increasing the dosage of ketorolac beyond the label recommendations (60–120 mg/day for a maximum of 2–5 days) will not provide better efficacy, but will increase the risk of serious adverse reactions [ ].
Organs and systems
Sensory systems
Reversible hearing loss with tinnitus and headache were described in a woman with a predisposition to ototoxicity in end-stage renal disease [ ].
Hematologic
Ketorolac prolongs the bleeding time reversibly. Serious bleeding, either at the operative site or in the gastrointestinal tract after perioperative administration of ketorolac, has been documented in several reports [ ] and in controlled studies [ ]. Concomitant use of anticoagulants increases the risk of bleeding [ ].
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