Results from a randomized double-masked phase 3 clinical trial, demonstrated the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% in children during cataract surgery.
In this multicenter study, children aged 0 to 3 years undergoing cataract surgery were randomized to receive 4 mL of PE/K 1.0%/0.3% or phenylephrine (PE) 1.0% injected into the surgical irrigation solution
Patients were assessed for up to 90 days after surgery. Change in pupil diameter from immediately prior to incision to wound closure was measured as well as postoperative pain at 3, 6, 9, and 24 hours following wound closure.
The mean change in pupil diameter was similar between groups but postoperative ocular pain scores and overall mean scores were lower in patients receiving PE/K at 3, 6, 9, and 24 hours. Differences in overall mean scores were statistically significant at 6 (P = 0.029) and 24 hours (P = 0.021).
The authors concluded PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery.
Wilson EM, Trivedi RH, Plager DA. Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management. J Cataract Refract Surg. 2020;46(6):873-878. doi: 10.1097/j.jcrs.0000000000000194