Pain reduction after laser in situ keratomileusis with ketorolac tromethamine ophthalmic solution 0.5%: a randomized, double-masked, placebo-controlled trial.

Author(s): Price FW Jr, Price MO, Zeh W, Dobbins K

Affiliation(s): Price Vision Group, Indianapolis, IN, USA. fprice@visiongroup.net

Publication date & source: 2002-03, J Refract Surg., 18(2):140-4.

Publication type: Clinical Trial; Evaluation Studies; Randomized Controlled Trial

PURPOSE: To evaluate the analgesic efficacy of ketorolac tromethamine ophthalmic solution 0.5% after laser in situ keratomileusis (LASIK). METHODS: In this two-center, randomized, double-masked, placebo-controlled, parallel group study, 39 patients underwent bilateral simultaneous LASIK. Patients received study drops (Acular PF or Lens Plus) in both eyes 15 to 30 minutes before surgery, again immediately before passing of the microkeratome, and again after flap repositioning. Proparacaine was used during surgery, but no additional therapeutics were used for the next 24 hours, except acetaminophen or propoxyphene napsylate acetaminophen allowed as escape medication. Patients rated their eye pain hourly through 6 hours after surgery. RESULTS: Ketorolac significantly reduced eye pain at every time point compared to placebo (P<.01). Escape medication use declined significantly; 16% (3/19) of those who received ketorolac required escape medication compared to 50% (8/16) of placebo-treated patients (P=.03). Ketorolac-treated eyes were pain-free significantly sooner (P<.01), with 47% (18/38) having pain cessation by hour 4, compared to 15% (5/33) of placebo-treated eyes. No treatment-related adverse events occurred. CONCLUSION: This study supports the use of topical ketorolac for control of early postoperative pain following LASIK, significantly increasing patient comfort and reducing usage of other pain medications.