Efficacy of topical ketorolac tromethamine 0.4% for control of pain or discomfort associated with cataract surgery

SUMMARY

Objective: To evaluate the efficacy of ketorolac 0.4% ophthalmic solution for control of pain and discomfort associated with cataract surgery.

Methods: This was a single-center, double-masked, randomized, fellow-eye placebo-controlled clinical study of 25 patients (mean age 72 years; 76% female) requiring bilateral cataract surgery. Patients received either ketorolac tromethamine 0.4% ophthalmic solution (Acular LS*) or placebo, 1 drop QID for 3 days prior to and 1 day following phacoemulsification and intraocular lens implantation on their first eye, and the other treatment for surgery on the second, fellow eye 1 week–4 weeks later. The physician rated patient cooperation and ocular pain or discomfort during surgery, and patients rated ocular pain or discomfort immediately and 24 h after surgery.

Results: Patients reported significantly less ocular pain during the 24 h following surgery when treated with ketorolac 0.4% than with placebo ( p = 0.02). Ocular pain was reported for only a single ketorolac 0.4%-treated eye (4%) during that period, compared with 39% of placebo-treated eyes ( p = 0.004). No significant differences between eyes treated with ketorolac 0.4% and placebo were observed in patient cooperation, and ocular pain or discomfort during or immediately after surgery. No adverse events occurred during the study.

Limitations: Evaluation of pain is subjective, and the severity of pain experienced in the control, vehicle-treated eyes was low.

Conclusions: The reduction in pain associated with cataract surgery afforded by ophthalmic ketorolac 0.4%, together with its favorable safety profile, make it an important tool to help surgeons meet the high expectations of today's cataract and refractive surgery patients.

Key words: :

• Cataract extraction
• Controlled clinical trial
• Ketorolac tromethamine
• Ophthalmic solutions
• Pain