Evaluation of the Safety of Ketorolac in Postsurgical Infants Less Than Six Months of Age.

OBJECTIVE:Ketorolac-related adverse events are not yet elucidated in neonates and infants given paucity of data. The objective of this research is to determine the incidence of major bleed in postsurgical neonates and infants treated with ketorolac, and to describe characteristics of ketorolac therapy and its effect on renal function. METHODS:This retrospective review assessed postsurgical patients younger than 6 months of age, without renal and/or coagulation dysfunction, who received ketorolac for postoperative pain during the study period. Major bleed was defined as a decrease in hemoglobin by ≥ 2 g/dL in a 24-hour period and/or intracranial, intraventricular, gastrointestinal, or pulmonary hemorrhage. Renal injury was identified per pediatric-modified RIFLE (risk, injury, failure, loss, end stage renal disease) criteria. RESULTS:One hundred twenty-five patients were analyzed, having a mean dosing weight of 5.6 kg, gestational age of 37.2 weeks, and postnatal age of 3.8 months. Ketorolac therapy was most frequently 0.5 mg/kg intravenously every 6 hours with a mean of 6.7 doses administered. The primary endpoint of major bleed occurred in 2 (1.6%) 2-month-old patients of 39 weeks' gestation. Both bleeds were characterized by decrease in hemoglobin without evidence of clinically significant bleeding. One (0.8%) and 3 (2.4%) patients experienced a decrease in glomerular filtration rate and urine output, respectively. Sixty-two (49.6%) patients received a concomitant medication associated with decreased bleeding risk. CONCLUSIONS:Ketorolac appears to have low incidence of major bleeds in postsurgical patients younger than 6 months of age without renal and/or coagulation dysfunction. Larger, prospective studies are needed to confirm safety of ketorolac use in this population.