The general purpose of this study is to characterize the safety profile of ketorolac in
infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective
in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg
intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9%
normal saline as placebo.
Primary: The primary purpose of this study is to compare bleeding events in neonates who
receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that
ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.
Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine
output per shift, platelet counts, hemoglobin levels, number of days on the ventilator,
amount of narcotic administered, blood pressure, and reintubation events on all patients in
this study as secondary study points.
Phase:
Phase 2
Details
Lead Sponsor:
Nationwide Children's Hospital
Collaborator:
The Research Institute at Nationwide Children's Hospital