Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions

Study objective: To determine whether the use of diclofenac ophthalmic solu tion is a safe and effective analgesic in the treatment of traumatic cornea l abrasions in the emergency department. Methods: We conducted a prospective, randomized, double-blinded, placebo-co ntrolled clinical trial. Consenting consecutive patients with corneal abras ions who presented to a community-based ED from August through February 199 8 were randomly assigned to receive either diclofenac or control vehicle dr ops. Pain relief was measured using a visual Numeric Pain Intensity Scale ( NPIS) before and after treatment. Exclusion criteria were as follows: age y ounger than 18 years, pregnancy, history of glaucoma, ocular infection, rec ent eye surgery, other signs of ocular trauma, narcotics within 6 hours, mi nimal pain (NPIS score <3), and any allergy to diclofenac or nonsteroidal a nti-inflammatory drugs. Patients were discharged with study drug or control vehicle solution, a topical antibiotic, oxycodone-acetaminophen as a rescu e analgesic, and a pain diary. The outcome measurements were improvement in NPIS score 2 hours after treatment, use of oxycodone-acetaminophen, and oc currence of any adverse effects. Results: Forty-nine patients were enrolled in the study; 25 received diclof enac and 24 received control vehicle drops. Both groups were similar in gen der, age, pretreatment pain duration, NPIS score, and analgesic use. There was significantly greater improvement in the 2-hour NPIS score in the diclo fenac group (3.1; 95% confidence interval [CI] 2.3 to 4) compared with the control group (1.0; 95% CI 0.1 to 2.0). The difference between the 2 groups was 2.1+/-1.3 (95% CI 0.8 to 3.4). There was a trend toward fewer patients taking rescue oxycodone-acetaminophen in the diclofenac group (20%; 95% CI 4% to 36%) versus the control group (42%; 95% CI 22% to 62%). Other than t ransient mild stinging, there were no complications associated with diclofe nac use. Conclusion: Diclofenac ophthalmic solution appears to be a safe and effecti ve analgesic in the treatment of traumatic corneal abrasions in the ED.