The Use of Ketorolac in Surgical Neonates

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: The Research Institute at Nationwide Children's Hospital
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

1. Infants gestational age > 37 weeks and greater than or equal to one week of age to 3 months of age

2. Infants who are undergoing a surgical procedure on the abdomen

3. the parent or guardian has given informed consent.

Exclusion Criteria:

1. Gestational age < 37 weeks

2. Age less than one week or greater than 3 months of age

3. Known renal disease/dysplastic kidneys

4. Serum Creatinine > 0.4

5. Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)

6. Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa [except for use of thrombosed central venous catheters], enalapril, systemic heparin [except for use in central venous catheter flushes])

7. Patients who undergo nephrectomy

8. Patients with necrotizing enterocolitis

9. Patients with a hemoglobin value < 10g/dL

10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation

11. Platelet count < 50,000

12. Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage

13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)

14. Allergy to ASA or other NSAIDS