Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients.

Abstract

PURPOSE:

To evaluate the safety and analgesic efficacy of ketorolac tromethamine 0.4% ophthalmic solution in postoperative photorefractive keratectomy (PRK) patients.

SETTING:

Fifteen clinical sites in the eastern and southern United States.

METHODS:

This pooled analysis of 2 multicenter, randomized, double-masked, vehicle-controlled, parallel-group studies comprised 313 patients having unilateral PRK. After surgery, patients were treated with 1 drop of ketorolac tromethamine 0.4% ophthalmic solution (Acular(R) LS) (n = 156) or vehicle (n = 157) 4 times daily for up to 4 days. Pain intensity, pain relief, use of escape medication, and severity of ocular symptoms were assessed. Adverse events, epithelial healing, and visual acuity were recorded.

RESULTS:

There was significantly less pain intensity experienced by patients in the ketorolac group (P<.001). During the first 12 hours post PRK, 50% fewer patients in the ketorolac group than in the vehicle group had severe to intolerable pain (41.6% [64/154] and 84.5% [131/155], respectively). The median time to no pain was 30 hours in the ketorolac group and 54 hours in the vehicle group (P<.001, survival analysis). Ketorolac patients reported significantly greater pain relief than vehicle patients throughout the study (P<.001). Ketorolac patients used significantly less escape medication than vehicle patients for 48 hours post PRK (P< or =.008). Treatment-related adverse events occurred in 2.6% (4/156) of ketorolac patients and 6.4% (10/157) of vehicle patients.

CONCLUSION:

Ketorolac 0.4% ophthalmic solution is safe and effective in reducing ocular pain when used 4 times daily for up to 4 days post PRK.

• Authors: Kerry D Solomon, Eric D Donnenfeld, Michael Raizman, Helga P Sandoval, Katherine Stern, Amanda VanDenburgh, Janet K Cheetham, Rhett Schiffman, Ketorolac Reformulation Study Groups 1 and 2
• Journal: Journal of cataract and refractive surgery (J Cataract Refract Surg) Vol. 30 Issue 8 Pg. 1653-60 (Aug 2004) ISSN: 0886-3350 [Print] United States
• PMID: 15313287 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Ophthalmic Solutions
• Ketorolac Tromethamine

Topics

• Adolescent
• Adult
• Aged
• Analgesia
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Ketorolac Tromethamine (adverse effects, therapeutic use)
• Lasers, Excimer
• Male
• Middle Aged
• Ophthalmic Solutions (adverse effects, therapeutic use)
• Pain Measurement
• Pain, Postoperative (drug therapy)
• Photorefractive Keratectomy
• Safety
• Visual Acuity