title: Analgesic efficacy and safety of nonpreserved ketorolac tromethamine ophthalmic solution following radial keratotomy. Ketorolac Radial Keratotomy Study Group.
abstract: OBJECTIVE
  To compare the analgesic efficacy and safety of nonpreserved ketorolac tromethamine 0.5% with those of its vehicle in the treatment of postsurgical ocular pain following radial keratotomy.
  
  
  METHODS
  This study employed a multicenter, double-masked, randomized, parallel-group design. Radial keratotomy patients were treated with either nonpreserved ketorolac tromethamine 0.5% or its vehicle four times daily for up to 3 days following surgery. Patients were provided with an escape medication (acetaminophen) for use only as needed for intolerable pain.
  
  
  RESULTS
  Patients treated with ketorolac reported significantly greater pain relief (P < or =.023), less pain intensity (P < or =.047), less use of escape medication (P < or =.001), fewer symptoms of ocular discomfort (P=.024), and fewer sleep disturbances (P < or =.013) than did patients treated with vehicle. No treatment-related adverse events were reported in the ketorolac group, and only one treatment-related adverse event was reported in the vehicle group. Most other safety findings were equivalent in the two treatment groups except that there were significantly less eyelid erythema (P=.026) and eyelid edema (P < or =.001) in the ketorolac group.
  
  
  CONCLUSIONS
  Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, vehicle in the treatment of postoperative pain associated with radial keratotomy. Therefore, topical ketorolac may be a valuable treatment option for the maintenance of patient comfort following refractive surgery.
authors.affiliation: University of Texas at Houston, 77030, USA. rwyee@eye.med.uth.tmc.edu
authors.forename: R W
authors.initials: RW
authors.lastname: Yee
mesh_terms: D000328:Adult; D000698:Analgesia / Q000379:methods*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003315:Cornea / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007646:Keratotomy, Radial / Q000009:adverse effects*; D020911:Ketorolac Tromethamine; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery; D009883:Ophthalmic Solutions; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D011310:Preservatives, Pharmaceutical; D012449:Safety; D014046:Tolmetin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014325:Tromethamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D014325:Tromethamine; D020911:Ketorolac Tromethamine; D014046:Tolmetin