Efficacy and safety of nonpreserved ketorolac ophthalmic solution in postoperative ocular pain following radial keratotomy

Purpose: To investigate the efficacy and safety of nonpreserved ketorolac t romethamine 0.5% ophthalmic solution in relieving pain following radial ker atotomy (RK). Setting: Multicenter clinical trial. Methods: Topical ketorolac was compared with its vehicle in a double-masked , randomized, parallel-group study involving 170 RK patients. Patients were treated with nonpreserved ketorolac 0.5% ophthalmic solution or the vehicl e 4 times daily beginning immediately after surgery and continuing for 3 da ys or until they no longer had ocular pain. Results: At several intervals, patients treated with ketorolac reported sig nificantly greater pain relief and less pain intensity than patients treate d with the vehicle. The time required for patients to first report "complet e relief" or "no pain" was shorter in the ketorolac than in the vehicle gro up (P less than or equal to.006). Patients in the ketorolac group used less escape medication (acetaminophen) (P less than or equal to .001) and had f ewer sleep difficulties (P less than or equal to .031), fewer symptoms of o cular discomfort (P less than or equal to .028), and less difficulty perfor ming activities of daily living (P = .048). Patients treated with ketorolac experienced the same low rate of treatment-related adverse events as those treated with the vehicle and exhibited the same improvement in visual acui ty and manifest refraction. Conclusions: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution w as significantly more effective than, and as safe as, the vehicle in allevi ating the postoperative pain associated with RK. This resulted in significa nt improvements in patient quality oi life and less need for oral analgesic s, suggesting that topical ketorolac is an appropriate treatment option for ocular pain following RK.