Preoperative Topical Diclofenac and Ketorolac in Prevention of Pain and Discomfort Following Photorefractive Keratectomy: A Randomized Double-masked Placebo-controlled Clinical Trial

Abstract

Objectives: To compare the efficacy of a single dose of topical diclofenac 0.1% and ketorolac 0.5%, with placebo and with each other in the prevention of post-PRK pain and discomfort.

Methods: In this randomized double-masked trial, adults undergoing bilateral PRK surgery were assigned to two arms. The first arm received a single dose diclofenac 0.1%, randomly in either the right, or left eye, and artificial tear (as the placebo) in the other eye. The second arm received ketorolac 0.5%, by the same pattern. The primary outcome of this study was ocular[1] pain assessed by visual analogue scale (VAS), and,[2] discomfort including itching, foreign body sensation, tearing and photophobia which were questioned in 4 degrees.

Results: In the final analysis, 47 and 36 subjects remained in the diclofenac and ketorolac treated arms, respectively. In both arms, on the first and second post-operation days, VAS scores were significantly lower in the pretreated eye. Moreover, on the first post-operation day, the intensity of all ocular discomfort items was statistically lower in the pretreated eyes; whereas, on the second day, such a difference was only observed for foreign body sensation and itching in the diclofenac treated arm and for photophobia in ketorolac treated arm. Comparison of the two arms (diclofenac pretreated eyes vs. ketorolac pretreated eyes) on both first and second post-operation days showed no significant difference neither in the VAS scores nor the ocular discomfort items.

Conclusions: Either diclofenac or ketorolac instilled at a dose of one drop 30 minutes in advance of the operation would be equally beneficial in the short-term prevention of post-PRK pain and discomfort.

Keywords: Photorefractive keratectomy, Diclofenac, Ketorolac, Pain, Discomfort, Prevention